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The effect of early probiotics intervention on the development of gestational diabetes mellitus in high-risk pregnant women and its mechanism based on intestinal flora

The effect of early probiotics intervention on the development of gestational diabetes mellitus in high-risk pregnant women and its mechanism based on intestinal flora

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045003
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes

Interventions

Probiotics intervention group:Take a pack of By-Health Probiotics daily
Control group:The same product placebo for useless biotics

Sponsors

Southeast University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged 33-45 years; 2. Body weight index (BMI)>= 24.0; 3. A family history of diabetes; history of abnormal glucose tolerance; a history of polycystic ovary syndrome. If there is one of them, we can determine the high-risk group of GDM; 4. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in or are participating in other clinical trials within three months of their first use of the study product; 2. Patients who are allergic to ingredients in the test sample or control sample; 3. Drugs that may affect the efficacy of the trial (such as hormones, anti-tumor drugs, sedatives or other muscle relaxants) are being used; 4. People with communication and cognitive difficulties; 5. Having a mental disorder; 6. Other patients considered by the investigator to be unsuitable for the study; 7. The compliance during the pre-experiment period fails to meet the requirements; 8. Pre-pregnancy diabetes mellitus, hypertension, and thyroid dysfunction; 9. multiple pregnancies; 10. Severe dysfunction of liver, kidney and heart; 11. A history of smoking and drinking.

Design outcomes

Primary

MeasureTime frame
Blood sugar;Intestinal flora;

Countries

China

Contacts

Public ContactSun Guiju

Southeast University

gjsun@seu.edu.cn+86 13951928860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026