NCT05273073

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Each sachet consists of 30 billion colony-forming units (CFU) of six viable probiotic strains (Lactobacillus acidophilus BCMC® 12130 (107 mg), Lactobacillus casei subsp. BCMC® 12313 (107 mg), Lactobacillus lactis BCMC® 12451 (107 mg), Bifidobacterium bifidum BCMC® 02290 (107 mg), Bifidobacterium infantis BCMC® 02129 (107 mg), and Bifidobacterium longum BCMC® 02120 (107 mg).
DIETARY_SUPPLEMENT	Placebo	Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.

Timeline

• Start date: 2018-03-01
• Primary completion: 2021-04-11
• Completion: 2021-04-26
• First posted: 2022-03-10
• Last updated: 2022-03-10

Locations

1 site across 1 country: Malaysia