Lactobacillus Johnsonii Supplementation in Adults With T1D

Evaluation of Safety, Tolerability and Immunological Responses to Lactobacillus Johnsonii N6.2 Supplementation in Adults With Diabetes Type 1

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Drug: L. johnsonii Probiotic; Drug: Placebo Capsule

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Michael Haller, MD; Phone Number: 352-273-9264; Email: hallemj@peds.ufl.edu
• Study Contact Backup: Name: Sarah Peeling, BS; Phone Number: 352-273-5275; Email: smpeeling@peds.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • UF Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: L. johnsonii Probiotic; Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
Placebo Comparator: 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.	Drug: Placebo Capsule; Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)	CBC and CMP will be evaluated at four different time points during study: 1st measure will be at screening visit and before starting intervention (visit 1/week -4, baseline period), 2nd measure will be after 12 weeks after starting intervention (visit 2/ week 12), 3rd measure will be after the 24 weeks of intervention (visit 3/ week 24) and the 4th measure will be 24 weeks later, end of washout period (visit 4/week 48). Values should be within the normal range except for glucose.	52 weeks
Tolerance will be evaluated according to their responses on weekly questionnaires	The weekly questionnaire will ask participants to respond to questions regarding their gastrointestinal health (bowel movement frequency, gastrointestinal and other symptoms (i.e., constipation, diarrhea, stomach pain) and general wellness (if you consumed an antibiotic, visited a doctor, etc.). The questionnaires follow a scale from 1-7, 1 = No discomfort at all, 7 = Very severe discomfort.	52 weeks
Adverse Event and/or Serious Adverse Event	Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24 hrs., in particular gastro-intestinal symptoms, fever and rashes.	24 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Michael Haller, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: genetics; probiotics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: IRB201901428 -N; OCR22502 (Other Identifier: UF OnCore); 1R01DK121130-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No