- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05273073
Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malaysia, 56000
- Universiti Kebangsaan Malaysia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Probiotics group
83 participants received probiotics for 12-week
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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).
Other Names:
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PLACEBO_COMPARATOR: Placebo group
83 participants received placebo for 12-week
|
Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean difference of fasting blood glucose (FBG)
Time Frame: 12-week
|
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
Time Frame: 12-week
|
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)
Time Frame: 12-week
|
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)
Time Frame: 12-week
|
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)
Time Frame: 12-week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean difference of body mass index (BMI)
Time Frame: 12-week
|
The detail for height was obtained from the antenatal record.
The weight of participants at the baseline and the end of the trial (post-12 weeks intervention) was measured.
BMI was calculated by dividing body weight (kg) with the square of the height (m2).
BMI was compared within each intervention group and between the two intervention groups
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12-week
|
Mean difference of waist circumference
Time Frame: 12-week
|
Waist circumference at the baseline and the end of the trial (post-12 weeks intervention) was measured and compared within each intervention group and between the two intervention groups
|
12-week
|
Mean difference of blood pressure
Time Frame: 12-week
|
Systolic and diastolic blood pressure 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 total cholesterol and triglycerides
Time Frame: 12-week
|
Total cholesterol and triglycerides 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 high sensitivity-C reactive protein (hs-CRP)
Time Frame: 12-week
|
hs-CRP 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 other inflammatory markers (interleukin-1β, IL-6, and IL-8)
Time Frame: 12-week
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IL-1β, IL-6, and IL-8 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
|
Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)
Time Frame: 12-week
|
Gut microbial composition, alpha diversity, beta diversity, and functional analysis at the baseline and at the end of trial (post-12 weeks intervention) were measured and compared within each intervention group and between the two intervention groups.
|
12-week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Professor Dr. Raja Affendi Raja Ali, Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKM PPI/111/8/JEP-2018-022
- AP-2017-008/2 (OTHER_GRANT: Ministry of Higher Education, Malaysia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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