NCT03109587

Pilot Study of Probiotics in Pre-diabetic Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vivomixx	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)
DIETARY_SUPPLEMENT	Placebo	maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-31
• Completion: 2020-07-31
• First posted: 2017-04-12
• Last updated: 2020-08-21

Locations

1 site across 1 country: United States