Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) (FMT)
![]() |
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: NCT02417974 |
Recruitment Status :
Terminated
(Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.)
First Posted : April 16, 2015
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Biological: Fecal Microbiota Transplant (FMT) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) |
Actual Study Start Date : | September 2015 |
Actual Primary Completion Date : | February 4, 2021 |
Actual Study Completion Date : | February 4, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT) via colonoscopy
|
Biological: Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT)
Other Names:
|
No Intervention: Control
No Fecal Microbiota Transplant (FMT) via colonoscopy
|
- Post-operative Endoscopic Recurrence [ Time Frame: within 6 months of ileo-cecal resection ]Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2
- Change in Microbial Diversity: Shannon Diversity Index [ Time Frame: baseline, 4, 12, and 26 weeks ]The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). Lower values indicate more diversity while higher values indicate less diversity.
- Number of Participants in Clinical Remission at 26 Weeks [ Time Frame: 26 weeks ]Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score <5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease.
- Adverse Events Frequency [ Time Frame: 4, 12, and 26 weeks ]Number of participants with adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Patients):
- Adults (age > 18)
- Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging (confirmed by Study PI for each site)
- Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to enrollment
- Resection margins & anastomosis free of active inflammation based on histology and surgical description (confirmed by Study PI for each site)
- No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior to enrollment.
Exclusion Criteria (Patients):
- Diagnosis of indeterminate colitis
- Women who are pregnant or nursing
- Patients who are unable to give informed consent
- Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
- Patients who have previously undergone FMT
- Patients who have a confirmed malignancy or cancer
- Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- Probiotic use within 30 days of start date
- Decompensated cirrhosis
- Congenital or acquired immunodeficiencies
- Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
- History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417974
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Alan C Moss, MD PhD | Boston Medical Center |
Documents provided by Boston Medical Center:
Responsible Party: | Boston Medical Center |
ClinicalTrials.gov Identifier: | NCT02417974 |
Other Study ID Numbers: |
H-34244 |
First Posted: | April 16, 2015 Key Record Dates |
Results First Posted: | March 24, 2022 |
Last Update Posted: | March 24, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Prevention Recurrence Fecal Microbiota Therapy |
Crohn Disease Recurrence Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Disease Attributes Pathologic Processes |