Lactobacillus Johnsonii in Children and Adolescents With T1D

Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D

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: Sarah Peeling; Phone Number: 352-273-5275; Email: smpeeling@peds.ufl.edu
• Study Contact Backup: Name: Michael Haller, MD; Phone Number: 352-273-9264; Email: hallemj@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: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 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: Prevention
• 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
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
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 values except for glucose.	52 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Juvenile Diabetes Research Foundation
• Investigators: Principal Investigator: Michael Haller, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Estimated): May 18, 2025
• Study Completion (Estimated): May 18, 2025

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: IRB201901369; 2-SRA-2019-811-M-B (Other Grant/Funding Number: Juvenile Diabetes Research Foundation); OCR22462 (Other Identifier: UF OnCore)

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