Back to results

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

Primary Purpose

Obesity, Childhood

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vivomixx

Placebo

About this trial

This is an interventional other trial for Obesity, Childhood

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seattle Children's Hosptital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vivomixx (Visbiome)

Placebo

Arm Description

2 packets of probiotics by mouth/day for 12 weeks

identical in appearance, but without probiotics.

Outcomes

Primary Outcome Measures

Change in microbiota composition

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

Secondary Outcome Measures

Change in insulin resistance

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

Change in inflammation in blood

measures of high sensitive cardio-reactive protein (hsCRP)

Change in inflammation in the gut

measure of fecal calprotectin

Full Information

NCT ID

NCT03109587

First Posted

March 27, 2017

Last Updated

August 19, 2020

Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT03109587

Brief Title

Pilot Study of Probiotics in Pre-diabetic Adolescents

Acronym

ProDP

Official Title

Pilot Study of Probiotics in Pre-diabetic Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seattle Children's Hospital

Collaborators

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Childhood

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The study product will be prepackaged and will be supplied and labeled only with the Protocol Number.

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vivomixx (Visbiome)

Arm Type

Active Comparator

Arm Description

2 packets of probiotics by mouth/day for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

identical in appearance, but without probiotics.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vivomixx

Intervention Description

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)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in microbiota composition

Description

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

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in insulin resistance

Description

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

Time Frame

baseline and 12 weeks

Title

Change in inflammation in blood

Description

measures of high sensitive cardio-reactive protein (hsCRP)

Time Frame

baseline and 12 weeks

Title

Change in inflammation in the gut

Description

measure of fecal calprotectin

Time Frame

baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian L Roth, MD

Organizational Affiliation

Seattle Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christiane S Hampe, PhD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seattle Children's Hosptital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34900780

Citation

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.

Results Reference

derived

Learn more about this trial

Pilot Study of Probiotics in Pre-diabetic Adolescents

We'll reach out to this number within 24 hrs