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Treating IBD With Inulin (TII)

Primary Purpose

Inflammatory Bowel Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oligofructose-enriched Inulin OI

Maltodextrin

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring diet, inulin, prebiotic, IBD, Inflammatory Bowel Disease

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept 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, 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

Sites / Locations

Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inulin

Placebo

Arm Description

Oligofructose-enriched Inulin (OI) administered for 8 weeks

Maltodextrin placebo administered for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in fecal calprotectin level

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

Full Information

NCT ID

NCT03653481

First Posted

August 28, 2018

Last Updated

September 21, 2022

Sponsor

Children's Hospital of Philadelphia

Collaborators

Beneo GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03653481

Brief Title

Treating IBD With Inulin

Acronym

TII

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

October 29, 2018 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

Beneo GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Diseases

Keywords

diet, inulin, prebiotic, IBD, Inflammatory Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inulin

Arm Type

Experimental

Arm Description

Oligofructose-enriched Inulin (OI) administered for 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrin placebo administered for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Oligofructose-enriched Inulin OI

Other Intervention Name(s)

Orafti®Synergy1

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Maltodextrin

Intervention Description

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

Primary Outcome Measure Information:

Title

Alteration of gut microbiota and metabolome

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in fecal calprotectin level

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica Breton, MD

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19146

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Treating IBD With Inulin

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