Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTOligofructose-enriched Inulin OIConsumed as a powder, 8g/d for children \<50kg and 16g/d for children ≥50kg, divided in 2 daily doses.
DIETARY_SUPPLEMENTMaltodextrinConsumed 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.