Pilot Study of Probiotics in Pre-diabetic Adolescents

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Childhood

In brief

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

Key facts

Study ID

NCT03109587

Run by

Seattle Children's Hospital

People needed

16

Starts

2018-06-01

Expected to finish

2020-07-31

Last updated by the study team

2020-08-21

Who can join

Age: 13 and older, up to 19. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, 13-19 y. of age at Visit 1.
• BMI: 99th percentile or greater
• Acanthosis nigricans
• Pubertal Tanner stage ≥3

You may not qualify if…

• 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

Where it is running

• Seattle Children's Hosptital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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