Lactobacillus Johnsonii in Children and Adolescents With T1D

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes (T1D)

In brief

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.

Key facts

Study ID

NCT03961854

Run by

University of Florida

People needed

30

Starts

2019-10-10

Expected to finish

2026-01-23

Last updated by the study team

2026-05-06

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have confirmed T1D by physician diagnosis
• have normal values at screening for complete blood count (CBC) and complete metabolic profiles (with the exception of fasting glucose and HbA1c)
• are able to swallow a capsule
• are willing to complete weekly online questionnaires
• are willing to consume a probiotic
• are willing to provide stool samples throughout the study
• are willing to provide blood samples throughout the study
• are willing to take three stimulated C-peptide tests
• are able to access a computer with Internet throughout the study

You may not qualify if…

• being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
• being treated for chronic kidney disease
• 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 Immunoglobulin A (IgA), Bruton's disease etc.)
• have an underlying structural heart disease
• currently live with an immunocompromised person
• are currently taking medications for constipation and/or diarrhea
• have taken antibiotics within the past 2 weeks prior to randomization
• are currently taking a probiotic supplement and are unwilling to discontinue it a minimum of 2 weeks prior to the study start
• are a current smoker
• are currently pregnant or lactating or a female who plans to become pregnant in the next 6 months
• have a known allergy to milk or milk protein.

Where it is running

• UF Clinical Research Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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