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

NCT05273073 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2022-03-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • B-Crobes Laboratory (M) Sdn Bhd

    collaborator UNKNOWN

  • Ministry of Higher Education, Malaysia

    collaborator OTHER

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Professor Dr. Raja Affendi Raja Ali · Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2021-04-11
Completion
2021-04-26

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273073 on ClinicalTrials.gov