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

NCT ID: NCT05273073

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-04-26

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Probiotics group

83 participants received probiotics for 12-week

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: 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).

Placebo group

83 participants received placebo for 12-week

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

HEXBIO® Microbial Cell Preparation (MCP)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

B-Crobes Laboratory (M) Sdn Bhd

UNKNOWN

Sponsor Role: collaborator

Ministry of Higher Education, Malaysia

OTHER

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

PROF DR RAJA AFFENDI RAJA ALI

Consultant Physician & Gastroenterologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Professor Dr. Raja Affendi Raja Ali

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia

Locations

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

AP-2017-008/2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

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

Identifier Type: -

Identifier Source: org_study_id