Lactobacillus Johnsonii Supplementation in Adults With T1D

NCT ID: NCT03961347

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2026-06-01

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic Group

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 Type: ACTIVE_COMPARATOR

L. johnsonii Probiotic

Intervention Type: DRUG

Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.

Placebo Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo Capsule

Intervention Type: DRUG

Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.

Interventions

L. johnsonii Probiotic

Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.

Intervention Type: DRUG

Placebo Capsule

Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have confirmed T1D by physician diagnosis
• Have normal values at screening for 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 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 internet access. However, if this changes once they are in the study, we will provide paper copies of the questionnaires.

Exclusion Criteria

• Have had or are currently being treated for any diseases or illnesses such as gastrointestinal 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 or conditions (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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Haller

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Clinical Research Center

Gainesville, Florida, United States

Countries

United States

Other Identifiers

OCR22502

Identifier Type: OTHER

Identifier Source: secondary_id

1R01DK121130-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201901428 -N

Identifier Type: -

Identifier Source: org_study_id