gestational diabetes mellitus (GDM)
Conditions
Interventions
Experimental group:Active ingredient intervention
Control group:Placebe
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 45 years old; 2. Person with Chinese nationality and yellow race; 3. Intrauterine live singleton pregnancy with gestation from 10+0 weeks to 11+6 weeks; 4. Pregnant women at high risk of GDM (i.e. having at least one risk factors of GDM); 5. Establishing the file of obstetric examination in Peking University Shenzhen Hospital; 6. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Diabetes before pregnancy; 2. Multiple pregnancy (pregnancy with the number of fetuses greater than or equal to 2); 3. Intake the medicines within 3 months, that may impact on glucose metabolic; 4. Intake the other dietary probiotics and/or fiber supplement within 3 months; 5. Persons involved in other clinical study; 6. Known allergic to probiotics or dietary fiber; 7. Diagnosis or history of chronic gastrointestinal disease, abnormal liver or kidney function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease of 75g-OGTT in 26-27 weeks of gestation compared with that of baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of HOMA-IR results compared between the before and after intervention;Analysis of the gut microbiome composition: alpha- and beta-diversity, relative abundance of short chain fatty acid producing bacteria;Incidence of GDM;weight change during pregnancyt;gut microbiota composition Analysis of the gut microbiome composition: alpha- and beta-diversity, relative abundance of short chain fatty acid producing bacteria;Newborn birth weight;Incidence of neonatal infection and asphyxia;Weight change during pregnancy;Adverse event; | — |
Countries
China
Contacts
Public ContactShilin Zhong
Peking University Shenzhen Hospital
Outcome results
None listed