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

FMT RECIPIENTS:

Participants will be recruited from the patient population treated by the Pediatric
Gastroenterology, Hepatology, and Nutrition Section at Baylor College of Medicine/Texas
Children's Hospital.

I. Activities prior to starting FMT therapy:

1. Participants will be asked to discontinue or taper their current home medications for
ulcerative colitis.

2. Participants will be asked to complete enema training.

3. The participant and family will be counseled in case emergency surgical and/or
intensive care interventions are required.

4. Survey Completion to assess clinical symptoms.

II. Initiation of FMT Therapy:

1. Pre-colonoscopy and FMT therapy preparation:

One to two days prior to scheduled colonoscopy the study participant will be asked to
provide a stool sample. They will also undergo a bowel clean-out with Miralax for
colonoscopy preparation. Colonoscopy (endoscopic examination of the large bowel) will
be used to deliver the first donor fecal transplant at the beginning of the therapeutic
protocol.

2. FMT treatment and Initial colonoscopy:

Fecal microbiota transplantation is made possible by utilizing a donor (healthy adult)
providing their stool sample. The donor's stool will be screened and tested for known
disease-causing agents including viruses, bacteria and parasites to prevent spread of
disease to the participant.

On the first day of treatment, the participant will undergo a colonoscopy to deliver the
filtered donor stool directly into their colon. Additionally, biopsies will be taken during
this procedure for routine diagnostic as well as research purposes.

III. Subsequent FMT treatments:

Enemas will be given periodically to complete a total of 1-year therapy.

IV. Follow-up endoscopy and samples:

A similar but more limited procedure (sigmoidoscopy) will be repeated at 14 weeks into the
study period. Biopsies will be taken during this procedure for routine diagnostic as well as
research purposes.

FMT DONORS:

Potential healthy adult stool donors (between 18 and 45 years of age) will be recruited by
the research staff. They will be asked to volunteer for the screening and regularly supply
stool samples according to the study protocol.

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