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

National University of Malaysia

Status

Completed

Conditions

Gestational Diabetes

Treatments

Dietary Supplement: Probiotics

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05273073

AP-2017-008/2 (Other Grant/Funding Number)

UKM PPI/111/8/JEP-2018-022

Details and patient eligibility

About

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.

Full 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.

Enrollment

166 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.