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Prebiotics for Type 1 Diabetes

N/A
Recruiting
Led By Raylene A Reimer, PhD, RD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Presence of active infection, pregnancy or lactation.
Previous intestinal surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial is testing whether prebiotics (a type of dietary fiber) can help improve glycemic control in newly diagnosed type 1 diabetes patients.

Who is the study for?
This trial is for individuals who have been diagnosed with type 1 diabetes within the last year and are at least 8 years old. They must not be taking medications or supplements that affect gut bacteria, have had intestinal surgery, active infections, pregnancy, lactation, or other chronic conditions like Crohn's disease.
What is being tested?
The study tests if prebiotic fiber can help manage blood sugar levels in people with new-onset type 1 diabetes by comparing a group taking prebiotics to another taking a placebo for six months as an addition to insulin therapy.
What are the potential side effects?
Potential side effects of prebiotics may include digestive discomfort such as bloating, gas, constipation or diarrhea. However, specific side effects will depend on individual reactions to the prebiotic supplement.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, or have an active infection.
Select...
I have had surgery on my intestines before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in frequency of hypoglycemia
Secondary study objectives
Change in Inflammatory marker IL-6
Change in Intestinal permeability
Change in dietary intake
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrebioticExperimental Treatment1 Intervention
Oligofructose-enriched inulin
Group II: PlaceboPlacebo Group1 Intervention
Maltodextrin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prebiotic
2016
Completed Phase 2
~800

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,239 Total Patients Enrolled
Raylene A Reimer, PhD, RDPrincipal InvestigatorUniversity of Calgary
6 Previous Clinical Trials
323 Total Patients Enrolled

Media Library

Prebiotic Clinical Trial Eligibility Overview. Trial Name: NCT04963777 — N/A
Type 1 Diabetes Research Study Groups: Prebiotic, Placebo
Type 1 Diabetes Clinical Trial 2023: Prebiotic Highlights & Side Effects. Trial Name: NCT04963777 — N/A
Prebiotic 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963777 — N/A
~39 spots leftby Dec 2025
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