Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases (GMT)
|ClinicalTrials.gov Identifier: NCT01560819|
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : December 4, 2013
Last Update Posted : December 30, 2013
Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC.
This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up.
Healthy donors >18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease (IBD)||Drug: Gut Microbial Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||June 2013|
Experimental: Study Participants
Participants did not receive any bowel preparation before Gut Microbial Transplantation (GMT). Audio-visual aids were used to help reduce participants' anxiety about GMT.
Drug: Gut Microbial Transplantation
Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.
Other Name: GMT
- Clinical Response [ Time Frame: 4 weeks following GMT Treatment ]Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560819
|United States, Michigan|
|Helen DeVos Children's Hospital of Spectrum Health Hospitals|
|Grand Rapids, Michigan, United States, 49503|
|Principal Investigator:||Sachin Kunde, MD, MPH||Helen DeVos Children's Hospital of Spectrum Health Hospitals|