Seattle Children's Hosptital
Seattle, Washington, 98105, United States
NCT Number: NCT03109587
This study evaluates the feasibility and effect of probiotics on glycemic control in obese adolescents.
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Notify Me13 year–19 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98105, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
Time frame: Baseline and 12 weeks
Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A
Time frame: baseline and 12 weeks
Measures of homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: baseline and 12 weeks
measures of high sensitive cardio-reactive protein (hsCRP)
Time frame: baseline and 12 weeks
measure of fecal calprotectin
Seattle Children's Hospital
Other
Acronym: ProDP
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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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