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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in frequency of hypoglycemia

Secondary outcome measures

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

~720

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,010 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have volunteered to take part in this trial?

"Affirmative, according to clinicaltrials.gov this medical study is actively seeking participation from the public. It was initially published on March 29th 2022 and most recently edited on June 30th 2022 with a goal of recruiting 144 individuals across 1 site."

Answered by AI

Is enrollment in this trial open at the moment?

"Affirmative, based on the information available on clinicaltrials.gov this research endeavor is still sourcing test subjects. The trial was first posted in late March 2022 and has been edited recently at the end of June 2022 with a goal to recruit 144 participants from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prebiotics in Newly Diagnosed Type 1 Diabetes

Dr. Raylene Reimer 2022. "Prebiotics in Newly Diagnosed Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04963777.