Prebiotic Fiber Supplement in T1DM Children
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Prebiotic
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Alberta Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Prebiotic
Arm Description
maltodextrin 3.3 g orally/ day for 12 weeks
1:1 oligofructose: inulin 8 g orally /day for 12 weeks
Outcomes
Primary Outcome Measures
Glycemic control (serum hemoglobin A1c)
measure serum level of hemoglobin A1c
Secondary Outcome Measures
Gut microbiota composition (mRNA in stool)
measure mRNA in stool
Gut microbiota composition (mRNA in stool)
measure mRNA in stool
Glycemic control (as measured by serum hemoglobin A1c)
measure serum level of hemoglobin A1c
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02442544
Brief Title
Prebiotic Fiber Supplement in T1DM Children
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
maltodextrin 3.3 g orally/ day for 12 weeks
Arm Title
Prebiotic
Arm Type
Experimental
Arm Description
1:1 oligofructose: inulin 8 g orally /day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic
Other Intervention Name(s)
OFS
Intervention Description
1:1 oligofructose: inulin 8 g orally /day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
maltodextrin 3.3g orally/day
Primary Outcome Measure Information:
Title
Glycemic control (serum hemoglobin A1c)
Description
measure serum level of hemoglobin A1c
Time Frame
3 month after start of trial
Secondary Outcome Measure Information:
Title
Gut microbiota composition (mRNA in stool)
Description
measure mRNA in stool
Time Frame
3 month after start of trial
Title
Gut microbiota composition (mRNA in stool)
Description
measure mRNA in stool
Time Frame
6 month after start of trial
Title
Glycemic control (as measured by serum hemoglobin A1c)
Description
measure serum level of hemoglobin A1c
Time Frame
6 month after start of trial
Other Pre-specified Outcome Measures:
Title
hypoglycemia (patient self report)
Description
patient self report
Time Frame
for the entire 6 month after start of the trial
Title
Change in gut permeability (quantification of specific sugars in urine)
Description
measure by amount of mannitol and lactulose in urine
Time Frame
3-month after start of the trial
Title
Change in gut permeability (quantification of specific sugars in urine)
Description
measure by amount of mannitol and lactulose in urine
Time Frame
6-month after start of the trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Huang, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Children's Hospital
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31188437
Citation
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.
Results Reference
derived
PubMed Identifier
27456494
Citation
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.
Results Reference
derived
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Prebiotic Fiber Supplement in T1DM Children
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