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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)
Are willing to consume a probiotic or placebo capsule daily for 24 weeks
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 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.Check my eligibility
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.See study design
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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I am willing to take a daily capsule for 24 weeks.
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My doctor has diagnosed me with Type 1 Diabetes.
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I can swallow pills.
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I am willing to fill out weekly online questionnaires.

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
1,338 Previous Clinical Trials
715,299 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,348 Previous Clinical Trials
4,314,675 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: NCT03961347 — 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: NCT03961347 — Phase 2
Lactobacillus johnsonii N6.2 (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961347 — Phase 2

Frequently Asked Questions

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

Who is eligible to volunteer for this clinical experiment?

"For this trial, 57 candidates aged 18 to 45 with type 1 diabetes mellitus are being sought. In addition to the age requirement, they must be able swallow a capsule, agree to complete weekly online questionnaires and take daily probiotic or placebo capsules for 24 weeks. Furthermore, participants should expect provide stool samples throughout the study as well as periodic blood tests and three 2-hour Mixed Meal Tolerance Tests (MMTTs)."

Answered by AI

What is the total enrollment count for this clinical experiment?

"Affirmative. According to information hosted on clinicaltrials.gov, this medical experiment is currently recruiting patients and has been since February 1st 2020. There have been recent updates made as of July 7th 2022 and the study aims to enroll 57 individuals from a single centre."

Answered by AI

Has the Probiotic Group obtained regulatory sanction by the FDA?

"Our evaluation at Power has assigned Probiotic Group a safety score of 2, indicating that the product is safe based on its Phase 2 trial but efficacy data remains inconclusive."

Answered by AI

Are any current participants being recruited for this trial?

"The pertinent information on clinicaltrials.gov confirms that this medical experiment, which was initially posted on February 1st 2020, is actively recruiting patients. The trial has been updated as recently as July 7th 2022."

Answered by AI

Is the age range for this trial limited to those above 65 years old?

"Prospective participants must be between 18-45 years old for this trial. There are 156 studies targeting those below the age of consent and 177 geared towards seniors aged 65+."

Answered by AI
~19 spots leftby Jun 2026