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OpenTrials
Completed

NCT Number: NCT03109587

Pilot Study of Probiotics in Pre-diabetic Adolescents

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

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hosptital

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Placebo

Dietary Supplement

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

Primary outcomes

  1. Change in microbiota composition

    Time frame: Baseline and 12 weeks

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

Secondary outcomes

  1. Change in insulin resistance

    Time frame: baseline and 12 weeks

    Measures of homeostatic model assessment of insulin resistance (HOMA-IR)

  2. Change in inflammation in blood

    Time frame: baseline and 12 weeks

    measures of high sensitive cardio-reactive protein (hsCRP)

  3. Change in inflammation in the gut

    Time frame: baseline and 12 weeks

    measure of fecal calprotectin

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • University of Washington

Registry information

Acronym: ProDP

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 12, 2017
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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