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Completed

NCT Number: NCT03961854

Lactobacillus Johnsonii 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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UF Clinical Research Center

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Immunoglobulin A (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.

Treatment and study plan

L. johnsonii Probiotic

Drug

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

Placebo capsule

Drug

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

Primary outcomes

  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 values 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 23, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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