Clinical trial NCT05273073: Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: gestational diabetes
probiotics
gut microbiota
glycemic control
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: B-Crobes Laboratory (M) Sdn Bhd
name: Ministry of Higher Education, Malaysia
First posted: 2022-03-10
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean difference of fasting blood glucose (FBG)
timeFrame: 12-week
measure: Mean difference of HbA1c
timeFrame: 12-week
measure: Mean difference of fasting serum insulin (FSI)
timeFrame: 12-week
measure: Mean difference of glucagon-like peptide -1 (GLP-1 active)
timeFrame: 12-week
measure: Mean difference of homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: 12-week
Secondary outcomes:
measure: Mean difference of body mass index (BMI)
timeFrame: 12-week
measure: Mean difference of waist circumference
timeFrame: 12-week
measure: Mean difference of blood pressure
timeFrame: 12-week
measure: Mean difference of total cholesterol and triglycerides
timeFrame: 12-week
measure: Mean difference of high sensitivity-C reactive protein (hs-CRP)
timeFrame: 12-week
measure: Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)
timeFrame: 12-week
measure: Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)
timeFrame: 12-week
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
name: Professor Dr. Raja Affendi Raja Ali
role: PRINCIPAL_INVESTIGATOR
References: