Recruiting at 3 sites No phase Type 1 Diabetes

Type 1 Diabetes study: Prebiotic

Official title Prebiotics in Patients With Type 1 Diabetes

ClinicalTrials.gov ID: NCT04963777

What this study is testing

What it's testing
The study will compare how often participants experience low blood sugar after 6 months of taking a prebiotic or a placebo, while still using insulin. It also aims to learn how the prebiotic might change gut bacteria and blood sugar control.
Who it's for
Adults and teens who have type 1 diabetes and use insulin.
What's involved
Participants will receive either a prebiotic supplement or a placebo for 6 months. They will keep a record of blood sugar levels, attend scheduled clinic visits, and may have blood and stool tests to examine gut bacteria.
Time commitment
The study lasts 6 months, with regular clinic visits and daily blood sugar monitoring throughout that period.
  • You might receive a placebo (an inactive treatment) instead of the study drug.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 7 and older

You may be able to join if

  • Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months.
  • Diagnosed with type 1 diabetes (based on Diabetes Canada 2018 Clinical Practice Guideline diagnostic criteria) in the previous 12 months.
  • Age 7 to 17 years of age.

You likely can't join if

  • Regular use of medications or supplements that could affect gut microbiota (examples: antibiotics, probiotic or prebiotic supplements, laxatives)...
  • Previous intestinal surgery.
  • Another chronic medical condition that could affect gut microbiota or intestinal permeability (examples: Crohn's disease, Celiac disease, colitis...
  • Presence of active infection, pregnancy or lactation.

The study team makes the final eligibility decision.

Where it is enrolling

  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Saskatoon, Saskatchewan, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 7 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Saskatoon, Saskatchewan, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.