Fecal Microbiota Transplantation for Ulcerative Colitis

Not Applicable

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Other: Fecal Microbiota Transplantation

• Registration Number: NCT01742754
• Lead Sponsor: University of Washington

Brief Summary

Fecal microbiota therapy (FMT) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). It is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. Several studies now report its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT in Ulcerative Colitis (UC) have also met with some success. This is corroborated by several lines of evidence suggesting dysbiosis plays an important role in UC pathogenesis. While a recent study using FMT in patients with irritable bowel syndrome (IBS) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in UC is not known. Indeed, there may be particular genetic or immunologic factors in UC leading to selection pressure preventing a change in the microbiota. As an initial step into investigating the potential efficacy of stool transplants for Ulcerative Colitis (UC), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate UC.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Mild to moderate UC.

Read More

Exclusion Criteria

• Antibiotic exposure in the last 3 months.
• Biologic or immunomodulatory therapy within the last 3 months.
• Corticosteroid therapy or probiotics within the last 2 weeks.
• Severely active disease (defined as Mayo scores of 10 or greater, or patients with endoscopic disease activity scores of 3 or greater).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation	Fecal Microbiota Transplantation	Fecal Microbiota Transplantation by colonoscopic delivery of stool to the right colon.

Primary Outcome Measures

Name	Time	Method
Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.	4 weeks	Metagenomic shotgun sequencing using Iluminia technology will be used to evaluate for engraftment. Metagenomic data will be analyzed using CompareReads. A % similarity to the recipient \> than % similarity to the donor will be defined as engraftment.

Secondary Outcome Measures

Name	Time	Method
Endoscopic remission at 4 weeks.	4 weeks	Mayo endoscopy scope of 0.
Durability of Fecal Microbiota Transplantation at 12 weeks	12 weeks	As in primary aim but at 12 weeks.
Engraftment of fecal microbiota transplantation at 7 days.	7 days	As in primary aim but at 7 days.
Clinical remission at 12 weeks.	12 weeks	Defined as Mayo score \<=2 with no subscore \>1
Number of patients with worsened disease.	4 weeks.	Increase in Mayo score of \>2.
Clinical remission at 4 weeks.	4 weeks	Defined as Mayo score \<=2 with no subscore \>1
Number of adverse events.	12 weeks.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States