Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02516384
• Date of registration: 29/07/2015
• Prospective Registration: Yes
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
• Scientific title: Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)
• Date of first enrolment: October 1, 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02516384
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Carl V Crawford, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with biopsy proven ulcerative colitis (UC), including those with inadequately
controlled UC (flare) as defined by failure of standard medical therapy,
steroid-dependence, and/or need for escalation of medical care as determined by
severity index (Mayo Score), endoscopic or histologic study, and/or medical provider

- Have active disease, defined with a Mayo Score > 3 and Mayo endoscopic subscore >1

- Subjects whom the investigator believes can and will comply with the requirements of
the protocol

- Able to provide informed written consent.

Exclusion Criteria:

- Biopsy-proven Crohn's disease or indeterminate colitis

- Acute abdomen or other clinical emergencies requiring emergent management (for
example: stricture, bowel obstruction, perforation and/or abscess)

- Primary sclerosing cholangitis (PSC)

- Pregnancy

- Concurrent Clostridium difficile infection or other known infection

- Prior history of fecal microbiota transplantation

- Other causes of diarrhea, including but not limited to tube feeds and medications (for
example, kayaxelate, metformin, lactulose, laxatives, magnesium)

- Major congenital defects

- Subjects with recent malignancy in the last 5 years, excluding non-melanoma skin
malignancies

- Anaphylactic reactions to any foods

- Any antibiotic use within the last 3 months

- Subject having any other condition that, in the opinion of the investigator, would
jeopardize the safety or rights of the participant participating in the study, would
make it unlikely for the participant to complete the study, or would confound the
study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: Fecal Microbiota Transplantation

Primary Outcome(s)

Safety post-FMT as determined by interview for adverse events [Time Frame: 36 months post-FMT]

Secondary Outcome(s)

Progression of disease defined by time to colectomy [Time Frame: up to three year follow-up period post fecal microbiota transplantation]

Clinical remission [Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation]

Progression of disease defined by clinical flare [Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation]

Microbial changes [Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation]

Progression of disease defined by increase in dosages of current UC medications [Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation]

Immunological changes [Time Frame: 0, 2 and 4 weeks post fecal microbiota transplantation]

Progression of disease defined by initiation of anti-TNF agents [Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation]

Death secondary to UC [Time Frame: Anytime during the three year follow-up period post fecal microbiota transplantation]

Clinical Response [Time Frame: 2, 4 and 12 weeks post fecal microbiota transplantation]

Secondary ID(s)

1404014982

Source(s) of Monetary Support

Please refer to primary and secondary sponsors