Pilot Study of Probiotics in Pre-diabetic Adolescents

Obesity, Childhood Clinical Trial

— ProDP  

Official title:

Pilot Study of Probiotics in Pre-diabetic Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109587
• Other study ID #: Probiotics/Diabetes Prevention
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Seattle Children's Hosptital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in microbiota composition	Microbiome (16S rRNA) analysis, fecal immunoglobulin (Ig)A	Baseline and 12 weeks
Secondary	Change in insulin resistance	Measures of homeostatic model assessment of insulin resistance (HOMA-IR)	baseline and 12 weeks
Secondary	Change in inflammation in blood	measures of high sensitive cardio-reactive protein (hsCRP)	baseline and 12 weeks
Secondary	Change in inflammation in the gut	measure of fecal calprotectin	baseline and 12 weeks