Pilot Study of Probiotics in Pre-diabetic Adolescents

NCT03109587 | Completed

• 1 other identifier: Probiotics/Diabetes Prevention
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (1)

• Change in microbiota composition

  Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A

  Baseline and 12 weeks

Secondary Outcomes (3)

• Change in insulin resistance

  baseline and 12 weeks

• Change in inflammation in blood

  baseline and 12 weeks

• Change in inflammation in the gut

  baseline and 12 weeks

Study Arms (2)

Vivomixx (Visbiome)

ACTIVE COMPARATOR

2 packets of probiotics by mouth/day for 12 weeks

Dietary Supplement: Vivomixx

Placebo

PLACEBO COMPARATOR

identical in appearance, but without probiotics.

Dietary Supplement: Placebo

Interventions

Vivomixx DIETARY_SUPPLEMENT

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)

Vivomixx (Visbiome)

Placebo DIETARY_SUPPLEMENT

maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)

Placebo

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Hosptital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 34900780 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian L Roth, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• Christiane S Hampe, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study product will be prepackaged and will be supplied and labeled only with the Protocol Number.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 12, 2017
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: July 31, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)