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Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women

Gestational Diabetes Clinical Trial

Official title:
Roles of Probiotics on Gut Microbiata Composition and Metabolic Outcomes in Women With a Recent History of Gestational Diabetes Mellitus: A Randomised Control Trial

Clinical Trial Summary

Risk of developing diabetes at a younger age among women with a previous history of gestational diabetes mellitus (post-GDM) has increased by 10-fold compared to the healthy women. However, consistent long-term lifestyle modifications by diet restriction and exercise are challenging. Interestingly, probiotics were found to balance gut bacteria and improve host metabolism. Thus, the aim of this study is to determine the beneficial roles of probiotics supplementation in post-GDM women.

Clinical Trial Description

Recent evidence highlighted disturbances in gut microbial compositions were associated with impairment of glucose and inflammation metabolism in women with GDM. Probiotics were hypothesized will modulate gut microbial compositions and maintain glucose and inflammation in the post-GDM women. This study aims to elucidate the roles of probiotic supplementation on metabolic and inflammatory outcomes in women with a previous history of gestational diabetes mellitus. This is a 12-week randomized, double-blind, placebo-controlled, parallel-group clinical trial involving participants who had attended postnatal follow-up at Universiti Kebangsaan Malaysia Medical Centre (UKMMC) with a recent history of GDM and had either postpartum glucose intolerance or overweight (body mass index (BMI) ≥23 kg/m2), or obese (BMI ≥27.5 kg/m2) during eligibility assessment. A total of 166 post-GDM participants with either postpartum glucose intolerance or overweight/obese were randomly assigned to probiotics (n = 83) and placebo (n= 83) groups. Eligible participants were given probiotics supplementation consisting of 30 billion colony forming units (CFU) of six viable microorganisms from Lactobacillus and Bifidobacteria strains, twice daily for 12-week. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05273073
Study type Interventional
Source National University of Malaysia
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date April 26, 2021
View Details
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