Pilot Study of Probiotics in Pre-diabetic Adolescents (ProDP)

Seattle Children's Healthcare System

Status

Completed

Conditions

Obesity, Childhood

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Vivomixx

Study type

Interventional

Funder types

Other

Identifiers

NCT03109587

Probiotics/Diabetes Prevention

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

13 to 19 years old

Volunteers

Accepts Healthy Volunteers

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