Fecal Microbiota Transplantation for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Evaluation of Durability of Fecal Microbiota Transplantation in Patients With Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01742754
• Other study ID #: 41454-K
• Status: Terminated
• Phase: N/A
• First received: November 29, 2012
• Last updated: November 11, 2013
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mild to moderate UC.

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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	The Broad Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful engraftment of donor fecal microbiota at 4 weeks post-transplantation.	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.	4 weeks	No
Secondary	Engraftment of fecal microbiota transplantation at 7 days.	As in primary aim but at 7 days.	7 days	No
Secondary	Durability of Fecal Microbiota Transplantation at 12 weeks	As in primary aim but at 12 weeks.	12 weeks	No
Secondary	Clinical remission at 4 weeks.	Defined as Mayo score <=2 with no subscore >1	4 weeks	No
Secondary	Clinical remission at 12 weeks.	Defined as Mayo score <=2 with no subscore >1	12 weeks	No
Secondary	Endoscopic remission at 4 weeks.	Mayo endoscopy scope of 0.	4 weeks	No
Secondary	Number of patients with worsened disease.	Increase in Mayo score of >2.	4 weeks.	Yes
Secondary	Number of adverse events.		12 weeks.	Yes