Pilot Study of Probiotics in Pre-diabetic Adolescents

Not Applicable

Completed

• Conditions: Obesity, Childhood
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Vivomixx

• Registration Number: NCT03109587
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2018-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	identical in appearance, but without probiotics.
Vivomixx (Visbiome)	Vivomixx	2 packets of probiotics by mouth/day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in microbiota composition	Baseline and 12 weeks	Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A

Secondary Outcome Measures

Name	Time	Method
Change in insulin resistance	baseline and 12 weeks	Measures of homeostatic model assessment of insulin resistance (HOMA-IR)
Change in inflammation in blood	baseline and 12 weeks	measures of high sensitive cardio-reactive protein (hsCRP)
Change in inflammation in the gut	baseline and 12 weeks	measure of fecal calprotectin

Trial Locations

Locations (1)

Seattle Children's Hosptital; 🇺🇸 Seattle, Washington, United States