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The Effect of a Multistrain Probiotic on Metformin Tolerance and Efficacy With Microbiota and Stool Metabolome in Insulin-resistant Women - a 12-week Randomized, Placebo-controlled, Double-blind Study

NCT06092060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-23

No results posted yet for this study

Summary

The goal of this study is to evaluate the efficacy of metformin on insulin sensitivity and vascular endothelial function with respect to gut microbiota and metabolome in women with established insulin resistance and its tolerance after 12 weeks of probiotic therapy.

The hypothesis is probiotic therapy in women with established insulin resistance undergoing metformin treatment increases the drug's efficacy to improve insulin sensitivity and intestinal endothelial function, and reduces gastrointestinal side effects.

Study participants will be randomly assigned to 2 groups, taking a probiotic (GS) or a placebo (GP). The randomization scheme will be computer-generated using permuted blocks of block size 4.

Conditions

Interventions

DIETARY_SUPPLEMENT

the group GS (probiotic)

The probiotic-supplemented group will receive 2 capsules of freeze-dried powder of a probiotic mixture containing the following bacterial strains twice a day, 3-month: Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus salivarius W24

DIETARY_SUPPLEMENT

the group GP (placebo)

The placebo group will receive 2 capsules consisting of the probiotic product carrier, which is corn starch and maltodextrin, twice a day, 3-month.

Sponsors & Collaborators

  • Poznan University of Physical Education

    lead OTHER

Principal Investigators

  • Joanna Karolkiewicz, Prof · Poznan University of Physical Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-02-01
Completion
2023-07-20

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06092060 on ClinicalTrials.gov