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Pilot Study of Probiotics in Pre-diabetic Adolescents

NCT03109587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-08-21

No results posted yet for this study

Summary

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

Conditions

  • Obesity, Childhood

Interventions

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)

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Christian L Roth, MD · Seattle Children's Hospital

  • Christiane S Hampe, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2020-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109587 on ClinicalTrials.gov