NCT02442544

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2015

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

March 10, 2015

Last Update Submit

April 17, 2019

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Glycemic control (serum hemoglobin A1c)

    measure serum level of hemoglobin A1c

    3 month after start of trial

Secondary Outcomes (3)

  • Gut microbiota composition (mRNA in stool)

    3 month after start of trial

  • Gut microbiota composition (mRNA in stool)

    6 month after start of trial

  • Glycemic control (as measured by serum hemoglobin A1c)

    6 month after start of trial

Other Outcomes (3)

  • hypoglycemia (patient self report)

    for the entire 6 month after start of the trial

  • Change in gut permeability (quantification of specific sugars in urine)

    3-month after start of the trial

  • Change in gut permeability (quantification of specific sugars in urine)

    6-month after start of the trial

Study Arms (2)

Placebo

PLACEBO COMPARATOR

maltodextrin 3.3 g orally/ day for 12 weeks

Dietary Supplement: Placebo

Prebiotic

EXPERIMENTAL

1:1 oligofructose: inulin 8 g orally /day for 12 weeks

Dietary Supplement: Prebiotic

Interventions

PrebioticDIETARY_SUPPLEMENT

1:1 oligofructose: inulin 8 g orally /day

Also known as: OFS
Prebiotic
PlaceboDIETARY_SUPPLEMENT

maltodextrin 3.3g orally/day

Placebo

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 8 - 17 years old
  • Diagnosed with type 1 diabetes for at least one year
  • HbA1c \<10% for 6 month prior to start of trial

You may not qualify if:

  • Subjects with another chronic medical condition that could affect gut microbiota (examples: Crohn's disease, cystic fibrosis, irritable bowel syndrome, etc.)
  • Subjects taking medications or supplements that could affect gut microbiota (examples: antibiotics, probiotics, prebiotics, laxatives, etc.)
  • Subjects with a positive celiac disease screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Related Publications (2)

  • Ho J, Nicolucci AC, Virtanen H, Schick A, Meddings J, Reimer RA, Huang C. Effect of Prebiotic on Microbiota, Intestinal Permeability, and Glycemic Control in Children With Type 1 Diabetes. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4427-4440. doi: 10.1210/jc.2019-00481.

    PMID: 31188437DERIVED

  • Ho J, Reimer RA, Doulla M, Huang C. Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial. Trials. 2016 Jul 26;17(1):347. doi: 10.1186/s13063-016-1486-y.

    PMID: 27456494DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Carol Huang, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2015

First Posted

May 13, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2018

Study Completion

December 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

CA(1)