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

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

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Dietary supplement: Vivomixx; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hosptital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vivomixx (Visbiome); 2 packets of probiotics by mouth/day for 12 weeks	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)
Placebo Comparator: Placebo; identical in appearance, but without probiotics.	Dietary supplement: Placebo; maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiota composition	Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A	Baseline and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington
• Investigators: Principal Investigator: Christian L Roth, MD, Seattle Children's Hospital; Principal Investigator: Christiane S Hampe, PhD, University of Washington

Publications and helpful links

General Publications

• Verma A, Nelson MT, DePaolo WR, Hampe C, Roth CL. A randomized double-blind placebo controlled pilot study of probiotics in adolescents with severe obesity. J Diabetes Metab Disord. 2021 Aug 8;20(2):1289-1300. doi: 10.1007/s40200-021-00855-7. eCollection 2021 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Prediabetic State
• Other Study ID Numbers: Probiotics/Diabetes Prevention

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No