Phase 1
N=20
Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Inflammatory Bowel Disease (IBD)
Bottom Line
View on ClinicalTrials.gov: NCT01560819 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Clinical Response — 9 Participants — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gut Microbial Transplantation (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Corewell Health West
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response |
9 | 0.03 sig |
Summary
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.
Eligibility Criteria
Participant Inclusion Criteria:
- Children ages >7 and ≤21 years of age with established diagnosis of Inflammatory Bowel Disease (IBD) colitis (patient with ulcerative colitis (UC) or patients with crohn's disease (CD) with colonic involvement only)
- Have clinical disease (mild to moderate disease: 10≤ Pediatric Ulcerative Colitis Activity Index (PUCAI)
- Oral thrush
- Disseminated lymphadenopathy
Data sourced from ClinicalTrials.gov (NCT01560819). 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.