TII: Treating IBD With Inulin

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT03653481

Collaborator

Beneo GmbH (Industry)

200

Enrollment

Location

Arms

50.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Dietary Supplement: Oligofructose-enriched Inulin OI Dietary Supplement: Maltodextrin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 29, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inulin Oligofructose-enriched Inulin (OI) administered for 8 weeks	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. Other Names: Orafti®Synergy1
Placebo Comparator: Placebo Maltodextrin placebo administered for 8 weeks	Dietary Supplement: Maltodextrin Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.

Arm

Intervention/Treatment

Experimental: Inulin

Oligofructose-enriched Inulin (OI) administered for 8 weeks

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.

Other Names:

Orafti®Synergy1

Placebo Comparator: Placebo

Maltodextrin placebo administered for 8 weeks

Dietary Supplement: Maltodextrin

Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.

Outcome Measures

Primary Outcome Measures

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

Change in fecal calprotectin level [8 weeks]
Change in fecal calprotectin following OI supplementation will be assessed 8 weeks after randomization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Males or females age 8-21 years.
Parental/guardian permission (informed consent) and child assent.
Pediatric diagnosis of inflammatory colonic or ileocolonic Crohn's disease (CD), ulcerative colitis (UC) or inflammatory bowel disease-unclassified (IBDU), as defined by endoscopy, radiology, and clinical findings.
Clinical disease activity index compatible with:
For patients with CD:
Pediatric Crohn's Disease Activity Index (PCDAI) ≤15 or short PCDAI (sPCDAI) ≤17.5 (if unable to complete full PCDAI) or physician global assessment (PGA) compatible with quiescent disease at time of enrollment
No visible blood in bowel movements in the 7 days prior to enrollment
Normal inflammatory laboratory markers (CRP, ESR, Albumin in the case of PCDAI)
For patients with UC/IBDU:
Pediatric Ulcerative Colitis Activity Index (PUCAI) ≤ 20 or PGA compatible with quiescent disease
No visible blood in bowel movements in the 7 days prior to enrollment
Fecal calprotectin (FC) ≥ 50 ≤ 500mcg/g or FC outside of this range but within the 20% margin of error of 500 mcg/g

Exclusion Criteria

Positive culture for an enteropathogen up to a month prior to enrollment or during the study period.
PCDAI >15 or sPCDAI >17.5 for patients with CD or PUCAI >20 for patients with UC or IBDU
Presence of an ostomy or prior colonic resection
Short bowel syndrome
Isolated perianal disease.
Patients requiring escalation of treatment 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-TNF therapy, or any other biologic therapy (ustekinumab, vedolizumab) for the preceding infusion or injection. De-escalation of therapy (i.e stopping a medication, or spacing the interval of medication or decreasing the dose of a medication) is acceptable.
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.
Use of commercially available prebiotic preparations during the preceding 3 weeks prior to starting the study drug or during the study period.
Non-inflammatory Crohn's disease (stricturing and/or penetrating disease behavior)
Isolated small bowel Crohn's disease
Previous ileocecal resection