Gestational DiabetesNCT05273073
Effects of Probiotics on Gut Microbiota Composition and Metabolic Outcomes in Post- Gestational Diabetes Women
A study testing Probiotics in people with Gestational Diabetes, run by National University of Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2018to 26 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Probiotics, Placebo
- Keywords
- gestational diabetes, probiotics, gut microbiota, glycemic control
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called HEXBIO® Microbial Cell Preparation (MCP)
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).
PlaceboDietary supplement
Placebo samples were identical to the probiotics in term of taste and texture without live microbial cells.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Active comparator | 83 participants received probiotics for 12-week Receives: Dietary Supplement: Probiotics |
| Placebo group | Placebo comparator | 83 participants received placebo for 12-week Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-week
Secondary outcomes (7)
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
Measured: 12-week
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
Measured: 12-week
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
Measured: 12-week
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.
Measured: 12-week
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.
Measured: 12-week
Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)
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.
Measured: 12-week
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.
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2018
- Primary completion11 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- B-Crobes Laboratory, Ministry of Higher Education, Malaysia
- Responsible party
- Principal investigator, PROF DR RAJA AFFENDI RAJA ALI, National University of Malaysia
- Investigators
- Professor Dr. Raja Affendi Raja Ali, Principal investigator, Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273073
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2018-022
- Other IDs
- AP-2017-008/2
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05273073
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2018-022
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, probiotics, gut microbiota, glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- B-Crobes Laboratory, Ministry of Higher Education, Malaysia
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 11 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Active comparator | Dietary Supplement: Probiotics83 participants received probiotics for 12-week |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo83 participants received placebo for 12-week |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsAlso: HEXBIO® Microbial Cell Preparation (MCP)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 | Probiotics group |
| PlaceboPlacebo samples were identical to the probiotics in term of taste and texture without live microbial cells. | Dietary supplement | Placebo group |
Primary outcome
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.
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.
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.
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.
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.
7 secondary outcomes
Mean difference of body mass index (BMI)
Time frame: 12-week
Mean difference of waist circumference
Time frame: 12-week
Mean difference of blood pressure
Time frame: 12-week
Mean difference of total cholesterol and triglycerides
Time frame: 12-week
Mean difference of high sensitivity-C reactive protein (hs-CRP)
Time frame: 12-week
Mean difference of other inflammatory markers (interleukin-1β, IL-6, and IL-8)
Time frame: 12-week
Changes in gut microbial profiles (i.e., gut microbial composition, alpha diversity, beta diversity, and functional analysis)
Time frame: 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Dr. Raja Affendi Raja Ali principal investigator
Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Gestational Diabetes, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of fasting blood glucose (FBG) (time frame: 12-week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.