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Probiotic

Lactobacillus Johnsonii Probiotic 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

Are willing to take three 2-hour Mixed-Meal Tolerance Tests (MMTTs)

Have confirmed T1D by physician diagnosis

Must not have

Are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial suggests that the probiotic Lactobacillus johnsonii N6.2 may help people with type 1 diabetes by preventing or restoring the gut flora and improving adaptive immunity.

Who is the study for?

Adults with confirmed Type 1 Diabetes who can swallow capsules, provide blood and stool samples, take tests, complete weekly questionnaires online, and consume a daily capsule for 24 weeks. Excluded are those allergic to milk proteins, living with immunocompromised individuals, having immune-compromising diseases or conditions (like HIV/AIDS), chronic kidney disease, heart disease or taking certain medications.

What is being tested?

The trial is testing whether the probiotic Lactobacillus johnsonii N6.2 can improve gut flora and affect immunity in people with Type 1 Diabetes to help preserve beta cell function. Participants will either receive this probiotic or a placebo capsule without knowing which one they're getting.

What are the potential side effects?

Potential side effects may include digestive discomfort such as bloating or gas due to changes in gut flora from the probiotic supplementation. Allergic reactions could occur but are unlikely given the exclusion of individuals with known allergies to milk protein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to undergo three 2-hour meal tests.

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My doctor has diagnosed me with Type 1 Diabetes.

Exclusion Criteria

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

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I am pregnant, breastfeeding, or plan to become pregnant soon.

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

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I have 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 / 7Eligibility criteria met