Phase 1
N=13
Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Disease · Crohn's Disease · Ulcerative Colitis · CD
Bottom Line
View on ClinicalTrials.gov: NCT01757964 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: 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 — 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Bacteriotherapy (Biological)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- David Suskind
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
13 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01757964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.