Skip to main content
OpenTrials
Completed

NCT Number: NCT05273073

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-45 years.
  • Attended postnatal follow-up at Universiti Kebangsaan Medical Center (four to eight weeks postpartum).
  • Have a recent history of gestational diabetes mellitus.
  • Willing to participate in the study.
  • Had either postpartum glucose intolerance, overweight (BMI ≥23 kg/m2), or obese (BMI ≥27.5 kg/m2) during eligibility assessment.

Exclusion criteria

  • Postpartum fasting blood glucose (FBG) level >8.0 mmol/L, two-hour postprandial (2HPP) glucose level >12 mmol/L.
  • Symptomatic of hyperglycemia and started on hypoglycemic agent.
  • Have underlying medical illnesses and required regular medications (i.e., pre- pregnancy diabetes, hypertension, congestive heart failure, renal failure, liver cirrhosis, gastrointestinal diseases, autoimmune diseases, and cancer) before and during intervention.
  • Had taken antibiotics / regularly consumed food or supplements rich in prebiotics/probiotics/symbiotics less than 12-week before recruitment or during intervention.

Treatment and study plan

Probiotics

Dietary Supplement

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).

Other names: HEXBIO® Microbial Cell Preparation (MCP)

Placebo

Dietary Supplement

Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.

Primary outcomes

  1. Mean difference of fasting blood glucose (FBG)

    Time frame: 12-week

    Fasting blood glucose (FBG) levels were measured at the baseline and at the end of trial (post-12 weeks intervention). The mean difference of FBG was obtained by comparing the FBG levels at the end of trial with FBG levels at baseline. The mean difference of FBG levels were assessed within each intervention group and between the two intervention groups.

  2. Mean difference of HbA1c

    Time frame: 12-week

    HbA1c levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  3. Mean difference of fasting serum insulin (FSI)

    Time frame: 12-week

    FSI levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  4. Mean difference of glucagon-like peptide -1 (GLP-1 active)

    Time frame: 12-week

    GLP-1 active levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  5. Mean difference of homeostasis model assessment of insulin resistance (HOMA-IR)

    Time frame: 12-week

    HOMA-IR levels at the baseline and at the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

Secondary outcomes

  1. Mean difference of body mass index (BMI)

    Time frame: 12-week

    The detail for height was obtained from the antenatal record. The weight of participants at the baseline and the end of the trial (post-12 weeks intervention) was measured. BMI was calculated by dividing body weight (kg) with the square of the height (m2). BMI was compared within each intervention group and between the two intervention groups

  2. Mean difference of waist circumference

    Time frame: 12-week

    Waist circumference at the baseline and the end of the trial (post-12 weeks intervention) was measured and compared within each intervention group and between the two intervention groups

  3. Mean difference of blood pressure

    Time frame: 12-week

    Systolic and diastolic blood pressure at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups

  4. Mean difference of total cholesterol and triglycerides

    Time frame: 12-week

    Total cholesterol and triglycerides levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  5. Mean difference of high sensitivity-C reactive protein (hs-CRP)

    Time frame: 12-week

    hs-CRP at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  6. Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)

    Time frame: 12-week

    IL-1β, IL-6, and IL-8 levels at the baseline and the end of the trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

  7. Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)

    Time frame: 12-week

    Gut microbial composition, alpha diversity, beta diversity, and functional analysis at the baseline and at the end of trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Collaborators

  • B-Crobes Laboratory (M) Sdn Bhd
  • Ministry of Higher Education, Malaysia

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.