This trial is active, not recruiting.

Conditions inflammatory bowel disease, crohn's disease, ulcerative colitis, cd
Treatment bacteriotherapy
Phase phase 1
Sponsor David Suskind
Collaborator Seattle Children's Hospital
Start date December 2012
End date October 2013
Trial size 20 participants
Trial identifier NCT01757964, 14267


In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.

Primary Outcomes

Response to Stool Transplantation
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 12 years up to 21 years old.

Inclusion Criteria: - Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease - Willing parent to donate stool for the transplant Exclusion Criteria: - Severe Disease - History of intra-abdominal abscess, intra-abdominal fistula or stricturing - History of other systemic diseases - The patient has received TNF inhibitors to treat their IBD within two months of transplant

Additional Information

Official title Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Seattle Children's Hospital.