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Fecal Microbiota Transplant (FMT) for Pouchitis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02428361
First Posted: April 28, 2015
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Najwa Elnachef, University of California, San Francisco
  Purpose

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.

Condition Intervention Phase
Pouchitis Drug: Biologically active human fecal material, OpenBiome Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Najwa Elnachef, University of California, San Francisco:

Primary Outcome Measures:
  • Clinical improvement of pouchitis [ Time Frame: 4 weeks ]

    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.



Secondary Outcome Measures:
  • Mucosal healing [ Time Frame: 6 months ]
    repeat pouchoscopy to determine


Estimated Enrollment: 30
Study Start Date: May 2015
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pouchitis patients receiving FMT
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
Fecal microbiota transplant

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:

  1. Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.
  2. Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.

Exclusion Criteria:

  1. Female patients who are pregnant.
  2. Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).
  3. Patients with diagnosis of ileal Crohn's Disease.
  4. Patients with untreated enteric infection.
  5. Patients with fistulizing disease.
  6. Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428361


Locations
United States, California
UCSF Division of Gastroenterology at Mount Zion
San Francisco, California, United States, 94143
Sponsors and Collaborators
Najwa Elnachef
  More Information

Responsible Party: Najwa Elnachef, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02428361     History of Changes
Other Study ID Numbers: 15-15859
First Submitted: April 17, 2015
First Posted: April 28, 2015
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases