Treating IBD With Inulin

NCT03653481 | Completed

• 1 other identifier: 18-015331
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

diet; inulin; prebiotic; IBD; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in fecal calprotectin level

  8 weeks

Study Arms (2)

Inulin

EXPERIMENTAL

Oligofructose-enriched Inulin (OI) administered for 8 weeks

Dietary Supplement: Oligofructose-enriched Inulin OI

Placebo

PLACEBO COMPARATOR

Maltodextrin placebo administered for 8 weeks

Dietary Supplement: Maltodextrin

Interventions

Oligofructose-enriched Inulin OI DIETARY_SUPPLEMENT

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

Also known as: Orafti®Synergy1

Inulin

Maltodextrin DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Beneo GmbH: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jessica Breton, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: October 29, 2018
• Primary Completion: June 30, 2022
• Study Completion: August 30, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)