NCT02417974

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant (FMT)	Fecal Microbiota Transplant (FMT)

Timeline

• Start date: 2015-09-01
• Primary completion: 2021-02-04
• Completion: 2021-02-04
• First posted: 2015-04-16
• Last updated: 2022-03-24
• Results posted: 2022-03-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study