Type 1 DiabetesEarly Phase 1NCT02442544
Prebiotic Fiber Supplement in T1DM Children
A Early Phase 1 study testing Prebiotic in people with Type 1 Diabetes, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Prebiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Dec 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Prebiotic, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Also called OFS
1:1 oligofructose: inulin 8 g orally /day
PlaceboDietary supplement
maltodextrin 3.3g orally/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | maltodextrin 3.3 g orally/ day for 12 weeks Receives: Dietary Supplement: Placebo |
| Prebiotic | Experimental | 1:1 oligofructose: inulin 8 g orally /day for 12 weeks Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (serum hemoglobin A1c)
measure serum level of hemoglobin A1c
Measured: 3 month after start of trial
Secondary outcomes (3)
Gut microbiota composition (mRNA in stool)
measure mRNA in stool
Measured: 3 month after start of trial
Gut microbiota composition (mRNA in stool)
measure mRNA in stool
Measured: 6 month after start of trial
Glycemic control (as measured by serum hemoglobin A1c)
measure serum level of hemoglobin A1c
Measured: 6 month after start of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2018
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Carol Huang, University of Calgary
- Investigators
- Carol Huang, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442544
- Sponsor's protocol ID
- OFSDM1
- Status last verified
- Apr 2019
- First submitted
- 10 Mar 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31188437Ho 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.
PubMed 27456494
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02442544
- Acronym / sponsor ID
- OFSDM1
- Conditions
- Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebomaltodextrin 3.3 g orally/ day for 12 weeks |
| Prebiotic | Experimental | Dietary Supplement: Prebiotic1:1 oligofructose: inulin 8 g orally /day for 12 weeks |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrebioticAlso: OFS1:1 oligofructose: inulin 8 g orally /day | Dietary supplement | Prebiotic |
| Placebomaltodextrin 3.3g orally/day | Dietary supplement | Placebo |
Primary outcome
Glycemic control (serum hemoglobin A1c)
Time frame: 3 month after start of trial
measure serum level of hemoglobin A1c
3 secondary outcomes
Gut microbiota composition (mRNA in stool)
Time frame: 3 month after start of trial
Gut microbiota composition (mRNA in stool)
Time frame: 6 month after start of trial
Glycemic control (as measured by serum hemoglobin A1c)
Time frame: 6 month after start of trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 31188437Ho 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.
- Derived from this study: PubMed 27456494Ho 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Huang, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Prebiotic in people with Type 1 Diabetes, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (serum hemoglobin A1c) (time frame: 3 month after start of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02442544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.