Fecal Microbiota Transplant for Inflammatory Bowel Disease
1 other identifier
interventional
59
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jun 2015
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2017
CompletedJune 21, 2018
June 1, 2018
1.6 years
May 28, 2015
June 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical improvement of IBD
In order to assess clinical improvement of IBD, patients will be scheduled for a 4 week post-FMT treatment clinic visit to assess patient symptoms.
4 weeks
Secondary Outcomes (1)
Efficacy of FMT treatment
4 weeks
Study Arms (1)
IBD patients receiving FMT
EXPERIMENTALIBD 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.
Interventions
Fecal microbiota transplant
Eligibility Criteria
You may qualify if:
- Patients with history of Ulcerative Colitis confirmed by endoscopy and pathology and with a Mayo clinic ulcerative colitits disease activity score of 6 or greater.
- 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 untreated enteric infection.
- Patients with colon cancer or dysplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Division of Gastroenterology at Mount Zion
San Francisco, California, 94143, United States
Related Publications (1)
Gutin L, Piceno Y, Fadrosh D, Lynch K, Zydek M, Kassam Z, LaMere B, Terdiman J, Ma A, Somsouk M, Lynch S, El-Nachef N. Fecal microbiota transplant for Crohn disease: A study evaluating safety, efficacy, and microbiome profile. United European Gastroenterol J. 2019 Jul;7(6):807-814. doi: 10.1177/2050640619845986. Epub 2019 Apr 20.
PMID: 31316785DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 2, 2015
Study Start
June 1, 2015
Primary Completion
December 20, 2016
Study Completion
November 4, 2017
Last Updated
June 21, 2018
Record last verified: 2018-06