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Lactobacillus Johnsonii in Children and Adolescents With T1D

Primary Purpose

Type 1 Diabetes (T1D)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L. johnsonii Probiotic
Placebo Capsule
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes (T1D) focused on measuring probiotics, genetics

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have been diagnosed with T1D for less than 1 year
  • 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)
  • have a Peak C-peptide >0.2 pmol/mL (0.6ng/mL)
  • are positive for at least one autoantibody (ICA, GAD-65, ZnT8 and IA-2A)
  • 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.

Sites / Locations

  • UF Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2019
Last Updated
August 7, 2023
Sponsor
University of Florida
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03961854
Brief Title
Lactobacillus Johnsonii in Children and Adolescents With T1D
Official Title
Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
May 18, 2025 (Anticipated)
Study Completion Date
May 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes (T1D)
Keywords
probiotics, genetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blinded, placebo-controlled clinical trial will be carried out with children and adolescents (8-less than 18 years old) with T1D
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
L. johnsonii Probiotic
Intervention Description
Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Intervention Description
Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.
Primary Outcome Measure Information:
Title
Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)
Description
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.
Time Frame
52 weeks
Title
Tolerance will be evaluated according to their responses on weekly questionnaires
Description
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.
Time Frame
52 weeks
Title
Adverse Event and/or Serious Adverse Event
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Haller, MD
Phone
352-273-9264
Email
hallemj@peds.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Peeling
Phone
352-273-5275
Email
smpeeling@peds.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Haller
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Lactobacillus Johnsonii in Children and Adolescents With T1D

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