Fecal Microbiota Transplant (FMT) for Pouchitis

NCT02428361 | Completed Early Phase 1 DMC

• 1 other identifier: 15-15859
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Pouchitis

Outcome Measures

Primary Outcomes (1)

• Clinical improvement of pouchitis

  In order to assess clinical improvement of pouchitis, patients will be scheduled for a 4 week post-FMT treatment clinic visit to ensure no adverse events have occurred and to assess patient symptoms. Patients will also complete a survey both before and after treatment to evaluate the efficacy of FMT treatment.

  4 weeks

Secondary Outcomes (1)

• Mucosal healing

  6 months

Study Arms (1)

Pouchitis patients receiving FMT

EXPERIMENTAL

Pouchitis patients receiving biologically active human fecal material sourced from OpenBiome.The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL through the endoscope. The material will be delivered to the most proximal point of insertion.

Drug: Biologically active human fecal material, OpenBiome

Interventions

Biologically active human fecal material, OpenBiome DRUG

Fecal microbiota transplant

Pouchitis patients receiving FMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:
• Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.
• Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.

You may not qualify if:

• Female patients who are pregnant.
• Patients with severe immunosuppression (absolute neutrophil count \< 1000 or CD4 count \<200).
• Patients with diagnosis of ileal Crohn's Disease.
• Patients with untreated enteric infection.
• Patients with fistulizing disease.
• Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules

Sponsors & Collaborators

• Najwa Elnachef: lead

Study Sites (1)

UCSF Division of Gastroenterology at Mount Zion

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 28, 2015
• Study Start: May 28, 2015
• Primary Completion: April 9, 2018
• Study Completion: March 4, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)