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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03109587
Recruitment Status : Not yet recruiting
First Posted : April 12, 2017
Last Update Posted : April 18, 2018
University of Washington
Information provided by (Responsible Party):
Christian Roth, Seattle Children's Hospital

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

Condition or disease Intervention/treatment Phase
Obesity, Childhood Dietary Supplement: Vivomixx Dietary Supplement: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The study product will be prepackaged and will supplied labeled only with the Protocol Number.
Primary Purpose: Other
Official Title: Pilot Study of Probiotics in Pre-diabetic Adolescents
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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)

Primary Outcome Measures :
  1. Change in microbiota composition [ Time Frame: Baseline and 12 weeks ]
    Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03109587

Contact: Christian L Roth, MD 206 987 5428
Contact: Susan Kearns, RN, MN 206 987-1758

Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Principal Investigator: Christian L Roth, MD Seattle Children's Hospital
Principal Investigator: Christiane S Hampe, PhD University of Washington

Responsible Party: Christian Roth, Professor, Seattle Children's Hospital Identifier: NCT03109587     History of Changes
Other Study ID Numbers: Probiotics/Diabetes Prevention
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Prediabetic State
Pediatric Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms