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

Gestational Diabetes Clinical Trial

Official title:

Roles of Probiotics on Gut Microbiata Composition and Metabolic Outcomes in Women With a Recent History of Gestational Diabetes Mellitus: A Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273073
• Other study ID #: UKM PPI/111/8/JEP-2018-022
• Secondary ID: AP-2017-008/2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: April 26, 2021

Study information

• Verified date: March 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: April 26, 2021
• Est. primary completion date: April 11, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur

Sponsors (3)

Lead Sponsor	Collaborator
National University of Malaysia	B-Crobes Laboratory (M) Sdn Bhd, Ministry of Higher Education Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean difference of body mass index (BMI)	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	12-week
Secondary	Mean difference of waist circumference	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
Secondary	Mean difference of blood pressure	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
Secondary	Mean difference of total cholesterol and triglycerides	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
Secondary	Mean difference of high sensitivity-C reactive protein (hs-CRP)	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
Secondary	Mean difference of other inflammatory markers (interleukin-1ß, IL-6, and IL-8)	IL-1ß, 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
Secondary	Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)	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