Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-06-01
2020-07-31
Brief Summary
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Detailed Description
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The probiotic strains are known to improve glycemic control.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Vivomixx (Visbiome)
2 packets of probiotics by mouth/day for 12 weeks
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
identical in appearance, but without probiotics.
Placebo
maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
Interventions
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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
maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
Eligibility Criteria
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Inclusion Criteria
* BMI: 99th percentile or greater
* Acanthosis nigricans
* Pubertal Tanner stage ≥3
Exclusion Criteria
* 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
13 Years
19 Years
ALL
Yes
Sponsors
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University of Washington
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
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Christian L Roth, MD
Professor
Principal Investigators
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Christian L Roth, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Christiane S Hampe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Seattle Children's Hosptital
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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Probiotics/Diabetes Prevention
Identifier Type: -
Identifier Source: org_study_id
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