Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Study Overview
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Brief Summary
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Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state. Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.

Official Title
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Modulation of Type 1 Diabetes Susceptibility Through VSL#3 Probiotic-induced Alterations in the Intestinal Microbiota

Conditions
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Type1diabetes, Type1 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: VSL#3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females 5-17 years of age Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes Treatment naïve of any immunomodulatory agent Naïve of any probiotic supplement within the past 12 months Exclusion Criteria: Presence of severe/active disease that interferes with dietary intake Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives Diagnosis of celiac disease and/or following a gluten-free diet Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting) Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics) Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results Female participants of child-bearing age must not be pregnant

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSL#3<br>Participants will be given the probiotic supplement VSL#3, a commercially available product. VSL#3 is taken by mouth, either once or twice daily, and is dispensed in sachets, each containing 450 billion colony forming units of bacterial strains. Participants will undergo a screening visit. They will be asked to provide a stool sample by the next visit. Within 3 weeks they will return with a stool sample and receive the VSL#3 sachets as well as another stool collection kit. After 6 weeks of taking VSL#3, they will return for their final visit, with their stool sample. Blood will be drawn at the second and third visits. | Dietary Supplement: VSL#3<br>* VSL#3 is a commercially available probiotic supplement manufactured and distributed by Alfasigma USA, Inc of Covington, Louisiana, USA. As with other probiotics, VSL#3 is considered a supplement and is not FDA-approved or regulated. VSL#3 contains eight probiotic strains: bifidobacteria (B. longum, B. infantis, and B. breve), lactobacilli (L. acidophilus, L. casei, L. bulgaricus, and L. plantarum) and Strepococcus thermophiles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations in Plasma-Induced Transcriptional Analysis | Examine the probiotic-induced alterations in the plasma-induced transcriptional analysis | 2 years (study duration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal Microbiota | Examine the intestinal microbiota, plasma microbial antigen levels as a marker of gut barrier function | 2 years (study duration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Siblings