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Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

NCT02417974•Boston Medical Center

Summary

The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+2 more criteria

Locations (2)

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

February 4, 2021

Completion Date

February 4, 2021

Last Updated

March 24, 2022

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Fecal Microbiota Transplant (FMT)

BIOLOGICAL

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease