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

Phase 2

Terminated

• Conditions: Crohn's Disease
• Interventions: Biological: Fecal Microbiota Transplant (FMT)

• Registration Number: NCT02417974
• Lead Sponsor: Boston Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Study Start: 2015-09
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Results First Submitted: 2022-01-03
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-26
• Last Update Submitted: 2022-02-26
• Results First Posted: 2022-03-24
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplant (FMT)	Fecal Microbiota Transplant (FMT)	Fecal Microbiota Transplant (FMT) via colonoscopy

Primary Outcome Measures

Name	Time	Method
Post-operative Endoscopic Recurrence	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

Secondary Outcome Measures

Name	Time	Method
Adverse Events Frequency	4, 12, and 26 weeks	Number of participants with adverse events
Change in Microbial Diversity: Shannon Diversity Index	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	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.

Trial Locations

Locations (2)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States