Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT01947101
• Date of registration: 13/09/2013
• Prospective Registration: Yes
• Primary sponsor: Baylor College of Medicine
• Public title: Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children FMT
• Scientific title: A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC)
• Date of first enrolment: February 2014
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01947101
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Richard Kellermayer, MD
• Affiliation: Baylor College of Medicine/Texas Children's Hospital

Key inclusion & exclusion criteria

Patient Inclusion Criteria:

- Patients must have a diagnosis of ulcerative colitis based on clinical symptoms, as
well as laboratory and colonoscopic findings, including histopathologic results of
the intestinal mucosa.

- Pediatric Ulcerative Colitis Activity Index (PUCAI) < 35 [mild activity] as assessed
within 4 weeks prior to enrollment and clinical symptoms that are at least stable.

- Patients must be "immunomodulator dependent," i.e., have a history of steroid
dependency (lack of clinical remission for over 8 weeks without steroid therapy),
and/or being immunomodulator (azathioprine, 6-mercaptopurine, methotrexate, etc.)
treated, and/or biologic agent (infliximab, adalimumab, etc.) treated

- Patients = 12 and < 21 years of age are eligible for this trial.

- Patients must be willing to be off current UC therapies.

- Willingness to undergo a surgical consultation prior to FMT treatment.

- Patients who are not enema trained will be required to undergo enema training prior
to the start of FMT treatment.

- All patients and/or their parents or legally authorized representatives must sign a
written informed consent document. Assent, when appropriate, will be obtained
according to institutional guidelines.

Patient Exclusion Criteria:

- Patients who are known to have the following will be excluded:

1. Decompensated liver cirrhosis (bleeding varices, ascites, encephalopathy or
icterus)

2. Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS)

3. Bone marrow transplantation within the past 150 days

4. Other severe immunodeficiency

- Patients with severe prior allergic reaction to food will be excluded from the
protocol.

- Patients who are pregnant or lactating will be excluded from the protocol.

Donor Inclusion Criteria:

- = 18 years and < 45 years

- Willing to provide stool and blood samples for laboratory testing.

- Body mass index < 30

- Willing to fill out a detailed health screening questionnaire



Age minimum: 12 Years
Age maximum: 20 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Biological: Fecal Microbiota Transplant

Primary Outcome(s)

Assess safety of FMT treatment by recording the frequency of adverse events. [Time Frame: 12 months]

Secondary Outcome(s)

Assess efficacy of FMT treatment with the aid of the Pediatric Ulcerative Colitis Activity (PUCAI) Index, a validated measure of clinical disease severity. [Time Frame: 1 year]

Secondary ID(s)

FMT- Ulcerative Colitis

H-30591

Source(s) of Monetary Support

Please refer to primary and secondary sponsors