Lactobacillus Johnsonii Supplementation in Adults With T1D

Last updated: April 1, 2025
Sponsor: University of Florida
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Mellitus, Type 1

Treatment

L. johnsonii Probiotic

Placebo Capsule

Clinical Study ID

NCT03961347
IRB201901428 -N
1R01DK121130-01A1
OCR22502
  • Ages 18-45
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have confirmed T1D by physician diagnosis

  • Have normal values at screening for CBC and complete metabolic profiles (with theexception of fasting glucose and HbA1c).

  • Are able to swallow a capsule.

  • Are willing to complete weekly online questionnaires.*

  • Are willing to consume a probiotic or placebo capsule daily for 24 weeks.

  • Are willing to provide stool samples throughout the study.

  • Are willing to provide blood samples throughout the study.

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

  • Are able to access a computer with Internet throughout the study.*

  • Note: Going into the study, we want the participants to have daily internetaccess. However, if this changes once they are in the study, we will providepaper copies of the questionnaires.

Exclusion

Exclusion Criteria:

  • Have had or are currently being treated for any diseases or illnesses such asgastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.).

  • Have chronic disease kidney disease.

  • Have had or are currently being treated for other immune-compromising diseases orconditions (HIV, AIDS, hepatitis, cancer, leukemia, transplant patient, Lupus,DiGeorge syndrome, selective deficiency of 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 aminimum 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 thenext 6 months.

  • Have a known allergy to milk or milk protein.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: L. johnsonii Probiotic
Phase: 2
Study Start date:
February 01, 2020
Estimated Completion Date:
June 01, 2026

Connect with a study center

  • UF Clinical Research Center

    Gainesville, Florida 32610
    United States

    Site Not Available

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