Treating IBD With Inulin



Status:Recruiting
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:8 - 21
Updated:11/9/2018
Start Date:October 29, 2018
End Date:October 2022
Contact:Caitlin Walsh
Email:walshc6@email.chop.edu
Phone:267-426-9249

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Safety and Feasibility of Oligofructose-Enriched Inulin in Quiescent Pediatric Inflammatory Bowel Disease

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.

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.

Inclusion Criteria:

- Males or females age 8-21 years.

- Parental/guardian permission (informed consent) and child assent.

- Pediatric diagnosis of IBD as defined by endoscopy, radiology, and clinical findings.

- Participant must be in clinical remission (for a minimum of 3 months at time of
enrollment) as defined by a Pediatric Crohn's Disease Activity Index (PCDAI), short
PCDAI or Pediatric Ulcerative Colitis Activity Index (PUCAI) score <10, and/or
Physician Global Assessment (PGA) consistent with quiescent disease.

- FC ≥ 50 < 500mgc/g.

Exclusion Criteria:

- Positive culture for an enteropathogen up to a month prior to enrollment or during the
study period.

- Clinically active disease as defined by a PCDAI, short PCDAI or PUCAI score ≥10.

- Presence of an ostomy or prior colonic resection.

- Short bowel syndrome

- Isolated perianal disease.

- Patients requiring escalation of treatment or not on a stable maintenance therapy
during the intervention or preceding enrollment, defined by the following: change in
dose of azathioprine/methotrexate during the preceding 12 weeks or 5-amino salicylic
acid during the preceding 2 weeks, change in dosing or interval of anti-tumour
necrosis factor (anti-TNF) therapy, or any other biologic therapy (ustekinumab,
vedolizumab) for the preceding infusion or injection.

- Use of oral steroids (with the exception of budesonide) within the last 4 weeks of the
screening visit or during the study period.

- Use of any antibiotics during the preceding 4 weeks or during the study period.

- Probiotics, or commercially available prebiotic preparations during the preceding 4
weeks or during the study period.
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 215-590-7801
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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