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

NCT05273073 | Completed DMC

• 2 other identifiers: UKM PPI/111/8/JEP-2018-022AP-2017-008/2
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; probiotics; gut microbiota; glycemic control

Outcome Measures

Primary Outcomes (5)

• Mean difference of fasting blood glucose (FBG)

  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.

  12-week

• Mean difference of HbA1c

  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.

  12-week

• Mean difference of fasting serum insulin (FSI)

  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.

  12-week

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

  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.

  12-week

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

  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.

  12-week

Secondary Outcomes (7)

• Mean difference of body mass index (BMI)

  12-week

• Mean difference of waist circumference

  12-week

• Mean difference of blood pressure

  12-week

• Mean difference of total cholesterol and triglycerides

  12-week

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

  12-week

Study Arms (2)

Probiotics group

ACTIVE COMPARATOR

83 participants received probiotics for 12-week

Dietary Supplement: Probiotics

Placebo group

PLACEBO COMPARATOR

83 participants received placebo for 12-week

Dietary Supplement: Placebo

Interventions

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).

Also known as: HEXBIO® Microbial Cell Preparation (MCP)

Probiotics group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with a recent history of gestational diabetes mellitus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead
• B-Crobes Laboratory (M) Sdn Bhd: collaborator
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Professor Dr. Raja Affendi Raja Ali

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician & Gastroenterologist

Model Details: 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.

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2018
• Primary Completion: April 11, 2021
• Study Completion: April 26, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)