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Probiotic

Probiotics for Type 1 Diabetes

Phase 2
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Antibiotic use within the past month
Uncontrolled celiac disease (i.e., consuming gluten) or actively being evaluated for possible celiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years (duration of study)

Summary

This trial will test whether the probiotic Lactiplantibacillus plantarum 299v (Lp299v) can help people newly diagnosed with Type 1 diabetes by reducing inflammation and preserving beta cell function.

Who is the study for?
This trial is for individuals aged 3-45 recently diagnosed with Type 1 Diabetes, who have at least one diabetes autoantibody. They must not have used probiotics or antibiotics in the past month and should not be on non-insulin hyperglycemia therapies. Women of childbearing age must use birth control during the study.
What is being tested?
The study tests if Lactiplantibacillus plantarum (a probiotic) can reduce inflammation and help maintain insulin-producing cell function in new Type 1 Diabetes patients by altering gut bacteria.
What are the potential side effects?
Potential side effects may include digestive discomfort, such as bloating or gas, which are common with probiotics. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken antibiotics in the last month.
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I have celiac disease that is not under control or am being tested for it.
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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years (duration of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years (duration of study) 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 composite inflammatory index after probiotic supplementation
Secondary study objectives
Markers of beta cell function
Markers of systemic microbial antigen exposure
Microbial composition as measured by 16s rRNA sequencing
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment GroupExperimental Treatment1 Intervention
Subjects will be randomized to the treatment or placebo group. The treatment is a capsule taken by mouth once a day for 6 months.
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects will be randomized to the treatment or placebo group. The placebo is a capsule taken by mouth once a day for 6 months.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
628 Previous Clinical Trials
1,179,816 Total Patients Enrolled

Media Library

Lactiplantibacillus plantarum 299v (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04335656 — Phase 2
Type 1 Diabetes Research Study Groups: Placebo Group, Treatment Group
Type 1 Diabetes Clinical Trial 2023: Lactiplantibacillus plantarum 299v Highlights & Side Effects. Trial Name: NCT04335656 — Phase 2
Lactiplantibacillus plantarum 299v (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04335656 — Phase 2
~7 spots leftby May 2025
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