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

Ulcerative Colitis Clinical Trial

Official title: A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC)

Status Completed

Clinical Trial Summary

Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an important role in the development of UC. There are many treatment options for UC such as steroids,and other medications that decrease inflammation. However, none of these can cure the disease.

This study aims to treat pediatric UC in an alternative fashion by changing the microbes in the gut by giving the participant's stool specimens from healthy adult individuals. There is some evidence from a few cases of adult UC that this therapy may cure the disease or at least provide long lasting suppression (remission) of the symptoms. The investigators would like to test this therapeutic intervention in children with UC.

The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3) The investigators will also study the effects of the treatment on colonic gene expression.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT01947101
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Completion date: May 2016