Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

June 30, 2013

Conditions
Inflammatory Bowel Disease (IBD)
Interventions
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.

Trial Locations (1)

49503

Helen DeVos Children's Hospital of Spectrum Health Hospitals, Grand Rapids

All Listed Sponsors
lead

Spectrum Health Hospitals

OTHER

NCT01560819 - Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases | Biotech Hunter | Biotech Hunter