Lactobacillus Johnsonii for Type 1 Diabetes
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a daily capsule with Lactobacillus johnsonii N6.2 or placebo for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lactobacillus johnsonii N6.2
Lactobacillus johnsonii N6.2 is already approved in United States for the following indications:
- Type 1 Diabetes (T1D)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Juvenile Diabetes Research Foundation
Collaborator