Bacteriotherapy in Pediatric Inflammatory Bowel Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01757964
• Date of registration: 22/12/2012
• Prospective Registration: No
• Primary sponsor: David Suskind
• Public title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
• Scientific title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
• Date of first enrolment: December 2012
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01757964
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

CD

Ulcerative Colitis

Crohn's Disease

Intervention(s)

Biological: Bacteriotherapy

Primary Outcome(s)

Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring [Time Frame: 2 weeks]

Secondary ID(s)

14267

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Seattle Children's Hospital

Results

• Results available: Yes
• Date Posted: 25/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01757964