Pilot Study of Probiotics in Pre-diabetic Adolescents

Study Overview
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Brief Summary
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This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.

Detailed Description
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Diet-induced intestinal dysbiosis in obese children contributes to the development of type 2 diabetes mellitus (T2D). Probiotic treatment has been proposed to alleviate glycemic dysfunction and prevent/delay development of T2D. The investigators will test probiotics to improve insulin sensitivity and preserve beta cell function in obese children. The probiotic strains are known to improve glycemic control.

Official Title
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Pilot Study of Probiotics in Pre-diabetic Adolescents

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Dietary Supplement: Vivomixx
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 13-19 y. of age at Visit 1. BMI: 99th percentile or greater Acanthosis nigricans Pubertal Tanner stage ≥3 Exclusion Criteria: Secondary diabetes (i.e. post-transplant diabetes mellitus (DM) or cystic fibrosis DM), monogenic forms of diabetes (i.e. MODY), autoimmune diabetes or presence of islet autoantibodies. Known severe immunodeficiency, or immune compromised. Current or previous history for insulin or metformin therapy (within last 3 months). Antibiotic or probiotic therapy 3 months prior to enrollment. Start of new dietary intervention within 1 month prior to enrollment. Diagnosed food hypersensitivity or active gastrointestinal disease

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vivomixx (Visbiome)<br>2 packets of probiotics by mouth/day for 12 weeks | Dietary Supplement: Vivomixx<br>* 900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)<br>|
| Placebo Comparator: Placebo<br>identical in appearance, but without probiotics. | Dietary Supplement: Placebo<br>* maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in microbiota composition | Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in insulin resistance | Measures of homeostatic model assessment of insulin resistance (HOMA-IR) | baseline and 12 weeks | 
| Change in inflammation in blood | measures of high sensitive cardio-reactive protein (hsCRP) | baseline and 12 weeks | 
| Change in inflammation in the gut | measure of fecal calprotectin | baseline and 12 weeks |