30 Participants Needed

Lactobacillus Johnsonii for Type 1 Diabetes

MH
MC
SP
Overseen BySarah Peeling
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications for constipation or diarrhea, or if you have taken antibiotics in the past 2 weeks. If you are taking a probiotic supplement, you must stop at least 2 weeks before the study starts.

What data supports the effectiveness of the treatment Lactobacillus johnsonii N6.2 for type 1 diabetes?

Research shows that Lactobacillus johnsonii N6.2 can reduce the development of type 1 diabetes in diabetes-prone rats by affecting certain immune responses. Additionally, it is well tolerated in healthy adults and influences immune cell populations, suggesting potential benefits for preventing type 1 diabetes.12345

Is Lactobacillus johnsonii safe for humans?

Lactobacillus johnsonii N6.2 has been shown to be safe in healthy adults, with no significant changes in blood tests and a reduction in symptoms like abdominal pain and indigestion. It is well tolerated and has positive effects on the immune system, making it a feasible option for further studies.12678

How is the treatment Lactobacillus johnsonii N6.2 unique for type 1 diabetes?

Lactobacillus johnsonii N6.2 is unique because it is a probiotic that may help prevent type 1 diabetes by changing the balance of certain substances in the body and supporting the immune system, unlike traditional treatments that focus on managing blood sugar levels.124910

What is the purpose of this trial?

While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.

Research Team

Michael J Haller, MD - Research - UF Health

Michael J Haller, MD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

I can swallow pills.
I am willing to fill out weekly online questionnaires.
are willing to provide blood samples throughout the study
See 11 more

Exclusion Criteria

I have or am being treated for a condition that weakens my immune system.
You are allergic to milk or milk protein.
I am receiving treatment for chronic kidney disease.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive a daily capsule with Lactobacillus johnsonii N6.2 or placebo for 24 weeks

24 weeks
3 visits (in-person) at weeks 0, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
1 visit (in-person) at week 48

Treatment Details

Interventions

  • Lactobacillus johnsonii N6.2
Trial Overview 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.
Participant Groups
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.

Lactobacillus johnsonii N6.2 is already approved in United States for the following indications:

🇺🇸
Approved in United States as Lactobacillus johnsonii N6.2 for:
  • Type 1 Diabetes (T1D)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Juvenile Diabetes Research Foundation

Collaborator

Trials
237
Recruited
142,000+

Findings from Research

The complete genome sequences of Lactobacillus johnsonii strain N6.2 and Lactobacillus reuteri strain TD1 were reported, providing valuable genetic information about these beneficial intestinal bacteria.
Both strains were isolated from a type 1 diabetes-resistant rat model, suggesting their potential role in gut health and disease resistance.
Complete Genome Sequences of Lactobacillus johnsonii Strain N6.2 and Lactobacillus reuteri Strain TD1.Leonard, MT., Valladares, RB., Ardissone, A., et al.[2021]
In a double-blind, randomized trial involving 42 healthy participants over 8 weeks, Lactobacillus johnsonii N6.2 was found to be safe and well-tolerated, with no significant changes in metabolic or blood cell profiles.
The probiotic treatment led to increased serum tryptophan levels and a decreased kynurenine:tryptophan ratio, along with significant changes in immune cell populations, suggesting potential immunological benefits that could support its use in preventing type 1 diabetes.
Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults.Marcial, GE., Ford, AL., Haller, MJ., et al.[2021]
In a study involving 96 children aged 8-17 with newly diagnosed type 1 diabetes, the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 did not significantly improve beta-cell function compared to a placebo over a 6-month period.
While there were no severe adverse effects reported, the probiotic group showed a higher incidence of thyroid autoimmunity, although this was also present at baseline, indicating the need for further research to determine the safety and efficacy of these probiotics in managing type 1 diabetes.
Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial.Groele, L., Szajewska, H., Szalecki, M., et al.[2022]

References

Complete Genome Sequences of Lactobacillus johnsonii Strain N6.2 and Lactobacillus reuteri Strain TD1. [2021]
Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults. [2021]
Lack of effect of Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 on beta-cell function in children with newly diagnosed type 1 diabetes: a randomised controlled trial. [2022]
Lactobacillus johnsonii N6.2 mitigates the development of type 1 diabetes in BB-DP rats. [2022]
Probiotic assisted weight management as a main factor for glycemic control in patients with type 2 diabetes: a randomized controlled trial. [2023]
The effect of Lactobacillus johnsonii Ncc533 (La1) on the balance of Th1/Th2 cells in BALB/c mice. [2019]
Urinary D-lactate excretion in infants receiving Lactobacillus johnsonii with formula. [2009]
Effects of the probiotic strain Lactobacillus johnsonii strain La1 on autonomic nerves and blood glucose in rats. [2013]
Complete genome sequence of Lactobacillus johnsonii FI9785, a competitive exclusion agent against pathogens in poultry. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Complete Genome Sequence of Lactobacillus johnsonii MR1, Isolated from a BALB/c Mouse Cecum. [2023]
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