Gestational Diabetes Mellitus (GDM)NCT06938464
Preventive Effect of Probiotics in GDM
A study testing Probiotics in people with Gestational Diabetes Mellitus (GDM), run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
- included between 12-16 gestational weeks
- A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+)
Who cannot join
- Taking probiotics or prebiotics within the past month
- Have a history of allergies to the drug components or similar drugs in this study
- Having long-term smoking or drinking habits
- Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
- Diseases in other important organs such as heart, liver, and kidney
- with clear digestive system diseases
- Multiple pregnancy
- with mental or cognitive impairments who are unable to complete this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xinning Chen, +8618817362544, jhviolet@163.com
About this study
Official title: The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Probiotics, Placebo
- 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
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
PlaceboDietary supplement
placebo with similar appearance and smell but not containing probiotics
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of gestational diabetes
The number of cases and incidence of gestational diabetes according to OGTT
Measured: 24-28th weeks gestation
Secondary outcomes (2)
The incidence of macrosomia
macrosomia refers to a newborn weighs more than 4 kg)
Measured: Delivery
Weight gain during pregnancy (kg)
Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start27 Oct 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Quzhou Maternity and Child Health Care Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938464
- Sponsor's protocol ID
- IRB-20230226-R
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06938464
- Acronym / sponsor ID
- IRB-20230226-R
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Quzhou Maternity and Child Health Care Hospital
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Apr 2025 (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.
Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsProbiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
Key exclusion criteria (8 listed)
- Taking probiotics or prebiotics within the past month
- Have a history of allergies to the drug components or similar drugs in this study
- Having long-term smoking or drinking habits
- Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
- Diseases in other important organs such as heart, liver, and kidney
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 |
|---|---|---|
| ProbioticsProbiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid | Dietary supplement | Probiotics |
| Placeboplacebo with similar appearance and smell but not containing probiotics | Dietary supplement | Placebo |
Primary outcome
the incidence of gestational diabetes
Time frame: 24-28th weeks gestation
The number of cases and incidence of gestational diabetes according to OGTT
2 secondary outcomes
The incidence of macrosomia
Time frame: Delivery
Weight gain during pregnancy (kg)
Time frame: Delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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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.
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 Mellitus (GDM), run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danqing Chen, Prof (86571-87061501, Chendq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of gestational diabetes (time frame: 24-28th weeks gestation). 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 27 Apr 2025.