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Treating IBD With Inulin (TII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03653481
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : March 6, 2020
Beneo GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Dietary Supplement: Oligofructose-enriched Inulin OI Dietary Supplement: Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 29, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

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 Name: 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.

Primary Outcome Measures :
  1. Alteration of gut microbiota and metabolome [ Time Frame: 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 :
  1. Change in fecal calprotectin level [ Time Frame: 8 weeks ]
    Change in fecal calprotectin following OI supplementation will be assessed 8 weeks after randomization.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03653481

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Contact: Lucie Dubes 267-426-9249
Contact: Sarah Dozil 267-426-8414

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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Lucie Dubes    267-426-9249   
Contact: Sarah Dozil    267-426-8414   
Principal Investigator: Jessica Breton, MD         
Sub-Investigator: Lindsey Albenberg, DO         
Sub-Investigator: Robert Baldassano, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Beneo GmbH
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Principal Investigator: Jessica Breton, MD Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT03653481    
Other Study ID Numbers: 18-015331
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases