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Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328547
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Olga Aroniadis, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome
Interventions Drug: Fecal microbiota transplantation capsules
Drug: Placebo capsules
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fecal Microbiota Transplantation Capsules First, Then Placebo Placebo Capsules First, Then Fecal Microbiota Transplantation
Hide Arm/Group Description

Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. Patients were crossed-over into the Placebo arm at 12 weeks. After cross-over, patients were administered 25 Placebo capsules, that did not contain donor stool or active drug, on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo dosing. The overall duration of the study was 6 months.

FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA.

Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo administration. Patients were then crossed-over into the FMT arm at 12 weeks. After cross-over, patients were administered 25 Fecal Microbiota Transplantation (FMT) capsules on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. The overall duration of the study was 6 months.

FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA.

Period Title: First Intervention (12 Weeks)
Started 25 23
Completed 22 23
Not Completed 3 0
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             2             0
Period Title: Second Intervention (12 Weeks)
Started 22 23
Completed 22 23
Not Completed 0 0
Arm/Group Title Fecal Microbiota Transplantation Capsules First, Then Placebo Placebo Capsules First, Then Fecal Microbiota Transplantation Total
Hide Arm/Group Description

Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).

FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA.

Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).

FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA.

Total of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
37.8  (12.3) 39.0  (11.7) 38.4  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
9
  36.0%
9
  39.1%
18
  37.5%
Male
16
  64.0%
14
  60.9%
30
  62.5%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   8.0%
2
   8.7%
4
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
21
  84.0%
19
  82.6%
40
  83.3%
More than one race
2
   8.0%
2
   8.7%
4
   8.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: 'More than one race' category identified as "Other" in study data
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 23 participants 48 participants
25 23 48
IBS-SSS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 23 participants 48 participants
282  (65) 309  (64) 294  (65)
[1]
Measure Description: Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) is measured on a scale range of 0-500 (min-max) via administration of a questionnaire. Higher scores are indicative of greater disease severity of symptoms based on a validated method. Subjects are categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology.
IBS-QOL   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 23 participants 48 participants
53  (18) 52  (18) 52  (18)
[1]
Measure Description: Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life.
Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 23 participants 48 participants
8.3  (4.7) 7.2  (3.6) 7.8  (4.2)
[1]
Measure Description:

The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which is administered via questionnaire. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.

HADS-A (Anxiety component)

Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 23 participants 48 participants
4.6  (4.3) 5.1  (3.0) 4.8  (3.7)
[1]
Measure Description:

The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which is administered via questionnaire. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.

HADS-D (Depression component)

Bristol Stool Form Scale (BSFS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 23 participants 48 participants
5.0  (0.8) 6.0  (0.9) 6.0  (0.9)
[1]
Measure Description: The Bristol Stool Form Scale is administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea.
1.Primary Outcome
Title Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)
Hide Description

Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology.

Only the following time points were analyzed: Baseline vs Week 12 and Week 24.

Time Frame Baseline, Week 12 (before cross-over), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 282  (65) 309  (64)
Week 12 221  (105) 236  (95)
Week 24 208  (111) 157  (101)
2.Secondary Outcome
Title Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score
Hide Description

Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Quality of Life (IBS-QOL), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life.

Only the following time points were analyzed: Baseline vs Week 12

Time Frame Baseline, Week 12 (before cross-over), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 53  (18) 52  (18)
Week 12 65  (18) 66  (17)
Week 24 70  (18) 76  (17)
3.Secondary Outcome
Title Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Hide Description

Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.

Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.

Time Frame Baseline, Week 1, Week 4 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FMT Responders FMT Non-responders
Hide Arm/Group Description:
Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: percentage of bacteria
Bacteroidetes - Baseline 0.41  (0.19) 0.35  (0.10)
Bacteroidetes - Week 1 0.43  (0.15) 0.34  (0.10)
Bacteroidetes - Week 4 0.38  (0.14) 0.34  (0.09)
Bacteroidetes - Week 12 0.47  (0.14) 0.34  (0.10)
4.Secondary Outcome
Title Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)
Hide Description

Anxiety at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)

The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.

Only the following time points were analyzed: Baseline vs Week 12

Time Frame Baseline, Week 12 (before cross-over), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 8.3  (4.7) 7.2  (3.6)
Week 12 8.6  (5.0) 7.4  (4.6)
Week 24 7.9  (4.8) 5.6  (3.6)
5.Secondary Outcome
Title Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)
Hide Description

Depression at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)

The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.

Only the following time points were analyzed: Baseline vs Week 12

Time Frame Baseline, Week 12 (before cross-over), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 4.6  (4.3) 5.1  (3.0)
Week 12 4.0  (4.1) 4.0  (2.6)
Week 24 3.8  (3.5) 3.4  (2.8)
6.Secondary Outcome
Title Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)
Hide Description

Bowel consistency as measured by the Bristol Stool Form Scale on a daily basis.

The Bristol Stool Form Scale was administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea.

Only the following time points were analyzed: Baseline vs Week 12

Time Frame Baseline, Week 12 (before cross-over), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks.
Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 5  (0.8) 6  (0.9)
Week 12 4  (1.0) 5  (1.1)
Week 24 4  (1.0) 4  (1.3)
7.Secondary Outcome
Title Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Hide Description The total number of participants in each of the arms/groups (FMT and Placebo) who experienced at least one adverse event (AE) as recorded in patient diaries.
Time Frame All AEs over 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were pooled together into one group.
Arm/Group Title FMT Capsules Placebo Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) either at the start of the trial or at cross-over (week 12).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) at the start of the trial or at cross-over (week 12).
Overall Number of Participants Analyzed 48 48
Measure Type: Count of Participants
Unit of Measure: Participants
Any Adverse Event
23
  47.9%
24
  50.0%
No Adverse Events
25
  52.1%
24
  50.0%
8.Secondary Outcome
Title Satisfaction With Fecal Microbiota Transplantation (FMT)
Hide Description Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Time Frame Week 12 following administration of FMT
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and, therefore, the outcome cannot be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT)
Hide Description Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries.
Time Frame Week 12 following administration of FMT
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and, therefore, the outcome cannot be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms
Hide Description The number of doctor or ED visits post-Fecal Microbiota Transplantation for Irritable Bowel Syndrome-D (IBS-D) related symptoms will be recorded in patient diaries.
Time Frame Week 12 following administration of FMT
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and, therefore, the outcome cannot be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms
Hide Description Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries.
Time Frame Week 12 following administration of FMT
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and, therefore, the outcome cannot be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)
Hide Description Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Time Frame Week 12 following administration of FMT
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected and, therefore, the outcome cannot be reported.
Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
Hide Arm/Group Description:
Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Tolerability of Fecal Microbiota Transplantation (FMT)
Hide Description Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries.
Time Frame Week 12 following administration of FMT
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Arm/Group Title FMT Capsules, Followed by Placebo Capsules Placebo Capsules, Followed by FMT Capsules
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Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
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Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.

Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.

The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index, the more diverse the intestinal microbiota.

Time Frame Baseline, Week 1, Week 4 and Week 12
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[Not Specified]
Arm/Group Title FMT Responders FMT Non-responders
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Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: index
Alpha Diversity - Baseline 3.96  (0.43) 4.16  (0.41)
Alpha-Diversity - Week 1 4.00  (0.41) 4.13  (0.28)
Alpha Diversity - Week 4 4.05  (0.59) 4.29  (0.29)
Alpha Diversity - Week 12 4.02  (0.62) 4.29  (0.29)
15.Secondary Outcome
Title Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
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Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.

Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.

The Beta Diversity Index or Jensen-Shannon divergence is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the intestinal microbiota between the two regions.

Time Frame Baseline, Week 1, Week 4 and Week 12
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[Not Specified]
Arm/Group Title FMT Responders FMT Non-responders
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Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: index
Jensen-Shannon Diversity - Baseline 0.52  (0.12) 0.48  (0.22)
Jensen-Shannon Diversity - Week 1 0.44  (0.16) 0.40  (0.16)
Jensen Shannon Diversity - Week 4 0.43  (0.14) 0.38  (0.16)
Jensen Shannon Diversity - Week 12 0.41  (0.16) 0.40  (0.15)
16.Secondary Outcome
Title Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
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Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.

Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.

Time Frame Baseline, Week 1, Week 4 and Week 12
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[Not Specified]
Arm/Group Title FMT Responders FMT Non-responders
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Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: percentage of bacteria
Firmicutes - Baseline 0.51  (0.19) 0.55  (0.12)
Firmicutes - Week 1 0.50  (0.15) 0.54  (0.11)
Firmicutes - Week 4 0.50  (0.13) 0.57  (0.12)
Firmicutes - Week 12 0.46  (0.12) 0.56  (0.09)
17.Secondary Outcome
Title Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
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Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.

Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. Information on abundance of Prevotella was only available at baseline and week 1.

Time Frame Baseline and Week 1
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[Not Specified]
Arm/Group Title FMT Responders FMT Non-responders
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Includes patients who received FMT capsules at the start of the clinical trial and who responded to FMT. FMT response was defined as a decrease of at least 50 points in the IBS-SSS at week 12 compared with baseline score.
Includes patients who received FMT capsules at the start of the clinical trial but who did not respond to FMT. FMT non-response was defined as a less than 50 point decrease in the IBS-SSS at week 12 compared with baseline score.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: percentage of bacteria
Prevotella - Baseline 0.12  (0.18) 0.04  (0.12)
Prevotella - Week 1 0.14  (0.19) 0.03  (0.09)
Time Frame 6 months
Adverse Event Reporting Description Adverse Events (AEs) were solicited during each patient visit. Additionally, patients, were asked to maintain a daily diary of AEs in a specifically dedicated diary developed by the research team to facilitate standardized reporting.
 
Arm/Group Title FMT Capsules Placebo Capsules
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25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12).

FMT capsules contained extensively screened donor stool and were prepared by OpenBiome, Medford, MA.

25 placebo capsules, that did not contain donor stool or any active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12).

Placebo capsules contained saline and glycerol. ann were prepared by OpenBiome, Medford, MA.

All-Cause Mortality
FMT Capsules Placebo Capsules
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)      0/48 (0.00%)    
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FMT Capsules Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/48 (0.00%)      1/48 (2.08%)    
Gastrointestinal disorders     
cholecystectomy  [1]  0/48 (0.00%)  0 1/48 (2.08%)  1
Indicates events were collected by systematic assessment
[1]
One study-unrelated SAE was reported. This participant underwent cholecystectomy for acute cholecystitis 2 months after ingesting placebo capsules.
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Frequency Threshold for Reporting Other Adverse Events 0%
FMT Capsules Placebo Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/48 (47.92%)      24/48 (50.00%)    
Gastrointestinal disorders     
Abdominal Pain   5/48 (10.42%)  4/48 (8.33%) 
Nausea   4/48 (8.33%)  2/48 (4.17%) 
Worsening of Diarrhea   3/48 (6.25%)  8/48 (16.67%) 
Constipation   2/48 (4.17%)  0/48 (0.00%) 
Bloating   2/48 (4.17%)  5/48 (10.42%) 
Regurgitation/Emesis   2/48 (4.17%)  0/48 (0.00%) 
Fatigue   2/48 (4.17%)  1/48 (2.08%) 
Gas   1/48 (2.08%)  4/48 (8.33%) 
Belching   1/48 (2.08%)  0/48 (0.00%) 
Loss of Appetite   1/48 (2.08%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Olga C. Aroniadis, PI
Organization: Montefiore Medical Center
Phone: 718-920-4846
EMail: oaroniad@montefiore.org
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Responsible Party: Olga Aroniadis, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02328547    
Other Study ID Numbers: 2014-3941
First Submitted: December 16, 2014
First Posted: December 31, 2014
Results First Submitted: September 4, 2018
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019