Treating IBD With Inulin (TII)

Safety and Feasibility of Oligofructose-Enriched Inulin in 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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Dietary supplement: Oligofructose-enriched Inulin OI; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, erythrocyte sedimentation rate (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-tumor necrosis factor (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alteration of gut microbiota and metabolome	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fecal calprotectin level	Change in fecal calprotectin following OI supplementation will be assessed 8 weeks after randomization.	8 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Beneo GmbH
• Investigators: Principal Investigator: Jessica Breton, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2018
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): August 30, 2022

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 28, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: prebiotic; Inflammatory Bowel Disease; IBD; diet; inulin
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 18-015331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No