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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

Must not have

Have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, organ transplant, Lupus, DiGeorge syndrome, selective deficiency of IgA, Bruton's disease etc.)

Being treated for chronic kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

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.

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.

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

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My doctor has diagnosed me with Type 1 Diabetes.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or am being treated for a condition that weakens my immune system.

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I am receiving treatment for chronic kidney disease.

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I have a heart condition related to the structure of my heart.

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I am currently on medication for constipation or diarrhea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 6Eligibility criteria met