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Trial record 1 of 1 for:    19171246 [PUBMED-IDS]
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Fecal Microbiota Transplantation to Treat Recurrent C. Difficile Associated Diarrhea Via Retention Enema or Oral Route

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ClinicalTrials.gov Identifier: NCT02449174
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
Roderick MacDonald Research Fund at Baylor St. Luke's
Kelsey Research Foundation
Texas Gulf Coast Digestive Diseases Center
Information provided by (Responsible Party):
Zhi-Dong Jiang, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition C. Difficile
Interventions Biological: Frozen Microbiota
Biological: Lyophilized Microbiota
Enrollment 69
Recruitment Details  
Pre-assignment Details One patient who enrolled never started treatment.
Arm/Group Title Frozen Microbiota Lyophilized Microbiota
Hide Arm/Group Description

Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema

Frozen Microbiota: Frozen Microbiota will be delivered via enema route.

Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally

Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.

Period Title: Overall Study
Started 36 32
Completed 36 32
Not Completed 0 0
Arm/Group Title Frozen Microbiota Lyophilized Microbiota Total
Hide Arm/Group Description

Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema

Frozen Microbiota: Frozen Microbiota will be delivered via enema route.

Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally

Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.

Total of all reporting groups
Overall Number of Baseline Participants 36 32 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Number Analyzed 36 participants 32 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  41.7%
15
  46.9%
30
  44.1%
>=65 years
21
  58.3%
17
  53.1%
38
  55.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
Female
26
  72.2%
21
  65.6%
47
  69.1%
Male
10
  27.8%
11
  34.4%
21
  30.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 32 participants 68 participants
36
 100.0%
32
 100.0%
68
 100.0%
Patients with IBD comorbidity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
5
  13.9%
6
  18.8%
11
  16.2%
1.Primary Outcome
Title Safety as Assessed by Number of Participants With Any Adverse Events (AE)s
Hide Description any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
Time Frame 6 months after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Frozen Microbiota Lyophilized Microbiota
Hide Arm/Group Description:

Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema

Frozen Microbiota: Frozen Microbiota will be delivered via enema route.

Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally

Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.

Overall Number of Participants Analyzed 36 32
Measure Type: Count of Participants
Unit of Measure: Participants
4
  11.1%
4
  12.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Frozen Microbiota, Lyophilized Microbiota
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8958
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants Who Continue to Have Diarrhea and C. Difficile Toxin Following Fecal Microbiota Transplantation From a Healthy Donor
Hide Description diarrhea was defined as more than 3 episodes of loose/watery stools in 2 consecutive days
Time Frame 60 days after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
subjects had more than 3 episodes of C. difficile infection and were treated with FMT
Arm/Group Title Frozen Microbiota Lyophilized Microbiota
Hide Arm/Group Description:

Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema

Frozen Microbiota: Frozen Microbiota will be delivered via enema route.

Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally

Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.

Overall Number of Participants Analyzed 36 32
Measure Type: Count of Participants
Unit of Measure: Participants
4
  11.1%
5
  15.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Frozen Microbiota, Lyophilized Microbiota
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2059
Comments [Not Specified]
Method Chi-squared, Corrected
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Frozen Microbiota Lyophilized Microbiota
Hide Arm/Group Description

Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was kept at -80C labeled with ID and expiration date which was 6 months after preparation. Intervention - Frozen Microbiota will be delivered via enema

Frozen Microbiota: Frozen Microbiota will be delivered via enema route.

Lyophilized Microbiota_Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 750mL, 1:5 dilution sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (750mL) was starting lyophilization process within 30 minutes after completion of stool filtration. Lyophilized microbiota products were kept at 4C and were used within 6 months after preparation. Intervention - Lyophilized Microbiota will be delivered orally

Lyophilized Microbiota: Lyophilized Microbiota will be delivered orally.

All-Cause Mortality
Frozen Microbiota Lyophilized Microbiota
Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)      2/32 (6.25%)    
Show Serious Adverse Events Hide Serious Adverse Events
Frozen Microbiota Lyophilized Microbiota
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/36 (11.11%)      3/32 (9.38%)    
Cardiac disorders     
Heart Failure  [1]  0/36 (0.00%)  0 2/32 (6.25%)  2
Gastrointestinal disorders     
Gastrointestinal related symptoms  [2]  1/36 (2.78%)  1 1/32 (3.13%)  1
Infections and infestations     
urine track infection  [3]  2/36 (5.56%)  2 0/32 (0.00%)  0
Nervous system disorders     
brain hematoma * 1 [4]  1/36 (2.78%)  1 0/32 (0.00%)  0
Stoke  [5]  0/36 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders     
pneumonia  [6]  0/36 (0.00%)  0 1/32 (3.13%)  1
1
Term from vocabulary, patient report
Indicates events were collected by systematic assessment
[1]
5 months after the procedure subject was hospitalized for COPD and emphysema
[2]
abdominal pain, vomiting, diarrhea, fever
[3]
bladder infection
*
Indicates events were collected by non-systematic assessment
[4]
subject was 97 years old, fell at home and hospitalized for brain hematoma
[5]
subject was hospitalized 14 days after the procedure
[6]
subject had previous history of pneumonia and was hospitalized with bilateral pneumonia 16 days after the procedure.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Frozen Microbiota Lyophilized Microbiota
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/36 (13.89%)      4/32 (12.50%)    
Gastrointestinal disorders     
gastrointestinal complaints * 1 [1]  2/36 (5.56%)  2 3/32 (9.38%)  3
General disorders     
headache   1/36 (2.78%)  1 0/32 (0.00%)  0
outpatient surgey for fracture   0/36 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations     
Bladder Infection   1/36 (2.78%)  1 0/32 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
breathing difficulty   1/36 (2.78%)  1 0/32 (0.00%)  0
1
Term from vocabulary, patient report
*
Indicates events were collected by non-systematic assessment
[1]
diarrhea, bowel pattern change
Indicates events were collected by systematic assessment
The study would have been improved by increasing the sample size to allow us to randomize subjects to three groups. In addition, while we assume that both procedures preserved spore-forming Clostridia, no spore counts were performed in this study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Herbert DuPont
Organization: University of Texas School of Public Health
Phone: 713 500 9366
Publications:
Responsible Party: Zhi-Dong Jiang, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02449174     History of Changes
Other Study ID Numbers: HSC-SPH-14-0020
First Submitted: December 17, 2014
First Posted: May 20, 2015
Results First Submitted: December 19, 2018
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019