| NCT ID | NCT06938464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University |
| Condition | Gestational Diabetes Mellitus (GDM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 334 participants |
| Start Date | 2023-10-27 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 334 participants in total. It began in 2023-10-27 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study. 1. included between 12-16 gestational weeks 2. 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 (+) Exclusion Criteria: 1. Taking probiotics or prebiotics within the past month 2. Have a history of allergies to the drug components or similar drugs in this study 3. Having long-term smoking or drinking habits 4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy 5. Diseases in other important organs such as heart, liver, and kidney 6. with clear digestive system diseases 7. Multiple pregnancy 8. with mental or cognitive impairments who are unable to complete this study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938464 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938464 currently recruiting?
Yes, NCT06938464 is actively recruiting participants. Contact the research team at Chendq@zju.edu.cn for enrollment information.
Where is the NCT06938464 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06938464 clinical trial?
NCT06938464 is sponsored by Women's Hospital School Of Medicine Zhejiang University. The trial plans to enroll 334 participants.
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