Lactobacillus Johnsonii in Children and Adolescents With T1D

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 1 Diabetes (T1D)

Intervention / Treatment
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* Drug: L. johnsonii Probiotic
* Drug: Placebo Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic Group<br>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<br>* Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.<br>|
| Placebo Comparator: Placebo Group<br>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<br>* Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.<br>|

What is the study measuring?
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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 values 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, genetics