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Probiotic

Lactobacillus Johnsonii for Type 1 Diabetes

Phase 2
Recruiting
Led By Michael Haller
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed T1D by physician diagnosis
Able to swallow a capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial suggests that the probiotic Lactobacillus johnsonii N6.2 may help prevent or restore gut flora in people with type 1 diabetes, potentially preserving beta cell function.

Who is the study for?
This trial is for children and adolescents with Type 1 Diabetes who can swallow capsules, provide blood and stool samples, complete online questionnaires, and take C-peptide tests. They must not have gastrointestinal diseases, recent antibiotic use, heart disease, live with immunocompromised individuals or be pregnant.Check my eligibility
What is being tested?
The study is testing whether the probiotic Lactobacillus johnsonii N6.2 can help maintain gut health and support immune function in young people with Type 1 Diabetes by comparing it to a placebo capsule.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or allergic reactions for those sensitive to milk proteins (as the probiotic may contain such), but generally probiotics are considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor has diagnosed me with Type 1 Diabetes.
Select...
I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Event and/or Serious Adverse Event
Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)
Tolerance will be evaluated according to their responses on weekly questionnaires

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Probiotic GroupActive Control1 Intervention
The probiotic group will receive a daily capsule with Lactobacillus johnsonii N6.2 1x109 CFUs. Participants will consume one capsule (treatment or placebo) daily for 24 weeks.
Group II: Placebo GroupPlacebo Group1 Intervention
The placebo group will receive a capsule daily with dried skim milk (vehicle of the probiotic). Participants will consume one capsule (treatment or placebo) daily for 24 weeks.

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,352 Previous Clinical Trials
723,393 Total Patients Enrolled
Juvenile Diabetes Research FoundationOTHER
234 Previous Clinical Trials
142,127 Total Patients Enrolled
Michael HallerPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

Lactobacillus johnsonii N6.2 (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03961854 — Phase 2
Type 1 Diabetes Research Study Groups: Probiotic Group, Placebo Group
Type 1 Diabetes Clinical Trial 2023: Lactobacillus johnsonii N6.2 Highlights & Side Effects. Trial Name: NCT03961854 — Phase 2
Lactobacillus johnsonii N6.2 (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961854 — Phase 2
~9 spots leftby May 2025
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