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| Name | Class |
|---|---|
| University of Washington | OTHER |
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This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivomixx (Visbiome) | Active Comparator | 2 packets of probiotics by mouth/day for 12 weeks |
|
| Placebo | Placebo Comparator | identical in appearance, but without probiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivomixx | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiota composition | Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A | Baseline and 12 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian L Roth, MD | Seattle Children's Hospital | Principal Investigator |
| Christiane S Hampe, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hosptital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34900780 | Derived | Verma A, Nelson MT, DePaolo WR, Hampe C, Roth CL. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec. |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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The study product will be prepackaged and will be supplied and labeled only with the Protocol Number.
|
| Placebo | Dietary Supplement | maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive) |
|
| baseline and 12 weeks |
| Change in inflammation in the gut | measure of fecal calprotectin | baseline and 12 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |