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Lactobacillus Johnsonii Supplementation in Adults With T1D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961347
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes (T1D) Drug: L. johnsonii Probiotic Drug: Placebo Capsule Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blinded, placebo-controlled clinical trial will be carried out in subjects between 18-45 years old with T1D.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Safety, Tolerability and Immunological Responses to Lactobacillus Johnsonii N6.2 Supplementation in Adults With Diabetes Type 1
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP) [ Time Frame: 52 weeks ]
    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.

  2. Tolerance will be evaluated according to their responses on weekly questionnaires [ Time Frame: 52 weeks ]
    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.

  3. Adverse Event and/or Serious Adverse Event [ Time Frame: 24 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have confirmed T1D (disease duration less than 3 years) physician diagnosis
  • Have normal values at screening for CBC and complete metabolic profiles (with the exception of fasting glucose and HbA1c).
  • Have a peak C-peptide ≥ 0.2 pmol/ml (0.6 ng/mL).
  • Are positive for at least one autoantibody (ICA, GAD-65, ZnT8 or IA-2A).
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961347


Contacts
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Contact: Michael Haller, MD 352-273-9264 hallemj@peds.ufl.edu
Contact: Miriam Cintron 352-273-5580 cintrm@peds.ufl.edu

Locations
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United States, Florida
UF Clinical Research Center Recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Michael Haller University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03961347    
Other Study ID Numbers: IRB201901428 -N
OCR22502 ( Other Identifier: UF OnCore )
1R01DK121130-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
probiotics
genetics
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases