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Prebiotic Fiber Supplement in T1DM Children

NCT02442544 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-04-18

No results posted yet for this study

Summary

The gut microbiome is increasingly recognized as a contributor to disease states. In type 1 diabetes, alterations in gut microbiota may be linked to changes in intestinal permeability, inflammation and insulin resistance. Prebiotic fiber is a dietary supplement that alters gut microbiota and could potentially improve insulin sensitivity in children with type 1 diabetes. This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with type 1 diabetes. The investigators hypothesize that consumption of prebiotic fiber will alter gut microbiota and intestinal permeability, leading to improved glycemic control. Prebiotic fiber is a potentially novel, inexpensive, low-risk treatment addition for type 1 diabetes that may improve glycemic control by changes in gut microbiota, gut permeability and inflammation.

Conditions

Interventions

DIETARY_SUPPLEMENT

Prebiotic

1:1 oligofructose: inulin 8 g orally /day

DIETARY_SUPPLEMENT

Placebo

maltodextrin 3.3g orally/day

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Carol Huang, MD, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-06-30
Completion
2019-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442544 on ClinicalTrials.gov