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Fecal Microbiota Transplant (FMT) for Pouchitis

NCT02428361 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-04-18

No results posted yet for this study

Summary

This is a prospective, open label pilot study in which patients with symptoms of acute or chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims our:

1. To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial Transplantation.
2. To determine if endoscopic appearance of ileal pouch improves following treatment by Fecal Microbial Transplantation.

Conditions

  • Pouchitis

Interventions

DRUG

Biologically active human fecal material, OpenBiome

Fecal microbiota transplant

Sponsors & Collaborators

  • Najwa Elnachef

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-28
Primary Completion
2018-04-09
Completion
2019-03-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428361 on ClinicalTrials.gov