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Prebiotic Fiber Supplement in T1DM Children

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ClinicalTrials.gov Identifier: NCT02442544
Recruitment Status : Active, not recruiting
First Posted : May 13, 2015
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Carol Huang, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Dietary Supplement: Prebiotic Dietary Supplement: Placebo Early Phase 1

Detailed Description:

At baseline, each subject will complete a demographic questionnaire (age, gender, date of type 1 diabetes diagnosis, current medications, other medical conditions, number of episodes of severe hypoglycemia and diabetic ketoacidosis since diagnosis of type 1 diabetes) and an anthropometric data form (height, weight, body mass index). A baseline stool sample will be collected at home. One tablespoon of stool will be placed in a pre-labelled sterile conical tube, placed in a biohazard bag and stored in the home freezer (-20°C). Stool samples will be brought to the laboratory on ice within 3 days from collection and stored at -80°C until analysis. Subjects will have a baseline blood sample drawn for HbA1c, C-peptide, and inflammatory markers (IL-6, IFN-γ, TNF-α, and IL-10), GLP1 and GLP2. An intestinal permeability test will be performed as described below.

Subjects will be randomized to receive either placebo (maltodextrin 3.3 g orally/ day) or prebiotic fiber (1:1 oligofructose: inulin 8 g orally /day). Both are approved as food ingredients in Canada and not regulated as natural health products. Dr. Reimer has a 'no objection' letter from Health Canada and has previously used these in a clinical trial (14).

Both prebiotic fiber and placebo come in a powder form in a pre-measured packet. Subjects will be instructed to mix the packet with 250 mL water until dissolved and to take 15-20 minutes prior to their evening meal. For the first two weeks, subjects will be asked to only take half of the dose in order to minimize GI side effects and then they will take the full dose for the remaining 10 weeks. Subjects will be asked to record any diabetes related adverse reactions (ie. severe hypoglycemia and diabetic ketoacidosis). At the end of the 12 weeks (3months), subjects will be asked to submit a second stool sample and repeat baseline blood tests and intestinal permeability testing. Subjects will be asked to return any remaining packets of placebo or prebiotic in order to assess for compliance. A third stool sample, intestinal permeability testing and blood sample (HbA1c, C-peptide, inflammatory markers (IL-6, IFN-γ, TNF-α, and IL-10), GLP1 and GLP2) will be done at 6 months follow up. Telephone contact from a member of the research team (research assistant or PI) will occur monthly to encourage compliance and recording of adverse reactions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prebiotic Fiber on Gut Microbiota, Intestinal Permeability and Glycemic Control in Children With Type 1 Diabetes: A Pilot Randomized, Double Blind, Placebo Controlled Study
Study Start Date : September 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
maltodextrin 3.3 g orally/ day for 12 weeks
Dietary Supplement: Placebo
maltodextrin 3.3g orally/day

Experimental: Prebiotic
1:1 oligofructose: inulin 8 g orally /day for 12 weeks
Dietary Supplement: Prebiotic
1:1 oligofructose: inulin 8 g orally /day
Other Name: OFS




Primary Outcome Measures :
  1. Glycemic control (serum hemoglobin A1c) [ Time Frame: 3 month after start of trial ]
    measure serum level of hemoglobin A1c


Secondary Outcome Measures :
  1. Gut microbiota composition (mRNA in stool) [ Time Frame: 3 month after start of trial ]
    measure mRNA in stool

  2. Gut microbiota composition (mRNA in stool) [ Time Frame: 6 month after start of trial ]
    measure mRNA in stool

  3. Glycemic control (as measured by serum hemoglobin A1c) [ Time Frame: 6 month after start of trial ]
    measure serum level of hemoglobin A1c


Other Outcome Measures:
  1. hypoglycemia (patient self report) [ Time Frame: for the entire 6 month after start of the trial ]
    patient self report

  2. Change in gut permeability (quantification of specific sugars in urine) [ Time Frame: 3-month after start of the trial ]
    measure by amount of mannitol and lactulose in urine

  3. Change in gut permeability (quantification of specific sugars in urine) [ Time Frame: 6-month after start of the trial ]
    measure by amount of mannitol and lactulose in urine



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02442544


Locations
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Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Carol Huang, MD, PhD University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Carol Huang, Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02442544     History of Changes
Other Study ID Numbers: OFSDM1
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases