Trials / Completed
CompletedNCT03653481
Treating IBD With Inulin
Safety and Feasibility of Oligofructose-Enriched Inulin in Pediatric Inflammatory Bowel Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Children's Hospital of Philadelphia · Academic / Other
- Sex
- All
- Age
- 8 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to see how the prebiotic inulin changes the gut bacteria (microbiome) of children and young adults with IBD and determine if this dietary intervention can help reduce disease activity.
Detailed description
The pathogenesis of inflammatory bowel disease (IBD) is thought to be due to a combination of genetic, environmental and immunological factors. From a clinical stand point, there is great interest in determining if manipulation of the gut microbiota may be a viable therapeutic strategy in IBD patients. One such strategy involves the use of prebiotic. Prebiotics are oligosaccharides that cannot be enzymatically hydrolyzed in the small intestine, however serve as substrates for fermentation by commensal bacteria in the colon. Investigators propose to evaluate the modulatory effects of the prebiotic inulin on the composition and function of the microbiota of children with IBD and determine the efficacy of this dietary intervention in reducing disease activity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Oligofructose-enriched Inulin OI | Consumed as a powder, 8g/d for children \<50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
| DIETARY_SUPPLEMENT | Maltodextrin | Consumed as a powder, 8g/d for children \<50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
Timeline
- Start date
- 2018-10-29
- Primary completion
- 2022-06-30
- Completion
- 2022-08-30
- First posted
- 2018-08-31
- Last updated
- 2022-09-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03653481. Inclusion in this directory is not an endorsement.