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Trial record 21 of 226 for:    Intestinal | maltodextrin

Treating IBD With Inulin (TII)

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ClinicalTrials.gov Identifier: NCT03653481
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
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 : 120 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. Fecal calprotectin change [ Time Frame: 8 weeks ]
    Assess the proportion of subjects in biochemical remission with Fecal calprotectin (FC) concentration <50 mcg/g 8 weeks after randomization


Secondary Outcome Measures :
  1. Alteration in gut microbiota and metabolome [ Time Frame: 16 weeks ]
    Assess the proportion of patients in remission with reduction of the FC concentration below 100 and 250 mcg/g among the subgroups with pre-randomization values above these levels.

  2. Occurrence of adverse events [ Time Frame: 8 weeks ]
    Safety and tolerability will be assessed based on the incidence of self-reported side effects



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

Inclusion Criteria:

  • Males or females age 8-21 years.
  • Parental/guardian permission (informed consent) and child assent.
  • Pediatric diagnosis of IBD as defined by endoscopy, radiology, and clinical findings.
  • Participant must have either quiescent or mild disease as defined by a PCDAI score ≤30 or short PCDAI ≤25 or PUCAI score <35, and/or PGA consistent with quiescent or mild disease at enrollment.
  • FC ≥ 50 ≤500mgc/g.

Exclusion Criteria:

  • Positive culture for an enteropathogen up to a month prior to enrollment or during the study period.
  • Clinically active disease as defined by a PCDAI >30 or short PCDAI score >25 or PUCAI score ≥35.
  • 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 1 week prior to starting the study drug or during the study period.

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 ClinicalTrials.gov identifier (NCT number): NCT03653481


Contacts
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Contact: Sarah Dozil 267-426-8414 dozils@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Lindsey Albenberg, DO    215-590-7801    albenbergl@email.chop.edu   
Contact: Sarah Dozil    267-426-8414    dozils@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
Beneo GmbH
Investigators
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Principal Investigator: Lindsey Albenberg, DO Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03653481     History of Changes
Other Study ID Numbers: 18-015331
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
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:
diet
inulin
prebiotic
IBD
Inflammatory Bowel Disease
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis