Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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).; Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.
Other intervention name(s): HEXBIO® Microbial Cell Preparation (MCP)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a 12-week randomized, double-blind, placebo-controlled, parallel-group clinical trial in post-gestational diabetes women. Participants were randomly received either placebo or 30 billion colony forming units of probiotics (HEXBIO® Microbial Cell Preparation, MCP® BCMC® Strains) consist of six viable microorganisms of Lactobacillus and Bifidobacteria strains, twice daily for 12-week.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: gestational diabetes; probiotics; gut microbiota; glycemic control