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Fecal Microbiota Transplant for Inflammatory Bowel Disease

NCT02460705 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-06-21

No results posted yet for this study

Summary

Currently enrolling only patients with Ulcerative Colitis. Enrollment and experimental treatment of patients with Crohn's Disease stopped for a safety evaluation.

This is a prospective, open label pilot study in which patients with symptoms of Inflammatory bowel disease will receive FMT therapy delivered via colonoscopy.

The investigators hypothesize that FMT is a safe and effective treatment for patients with inflammatory bowel disease. The aims are:

1. To determine if symptoms of inflammatory bowel disease can be successfully treated by Fecal Microbial Transplantation.
2. To determine if endoscopic appearance of colon or ileum improves following treatment by Fecal Microbial Transplantation.

Conditions

Interventions

DRUG

Biologically active human fecal material, OpenBiome

Fecal microbiota transplant

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-20
Completion
2017-11-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02460705 on ClinicalTrials.gov