Treating IBD With Inulin

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Dietary Supplement: Oligofructose-enriched Inulin OI; Dietary Supplement: Maltodextrin

• Registration Number: NCT03653481
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-31
• Study Start: 2018-10-29
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inulin	Oligofructose-enriched Inulin OI	Oligofructose-enriched Inulin (OI) administered for 8 weeks
Placebo	Maltodextrin	Maltodextrin placebo administered for 8 weeks

Primary Outcome Measures

Name	Time	Method
Alteration of gut microbiota and metabolome	8 weeks	The primary outcome will be assessed based on specific inulin-induced changes in microbiome composition and metabolome with a focus on short-chain fatty acid (SCFA) producers and their metabolites at week 8.

Secondary Outcome Measures

Name	Time	Method
Change in fecal calprotectin level	8 weeks	Change in fecal calprotectin following OI supplementation will be assessed 8 weeks after randomization.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States