Gut Microbiota, SCFAs and Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns

Gut Microbiota Clinical Trial

Official title:

Study on the Relationship of Gut Microbiota and Changes of SCFAs With Glucolipid Metabolism in Pregnant Women With Abnormal Fetal Size and Their Newborns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399434
• Other study ID #: SAHoWMU-CR2020-07-209
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: May 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Ying Hua
• Phone: +8613676403165
• Email: wzfeyhy1015[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Abnormal fetal size includes fetal growth restriction and fetal macrosomia. Onset is closely related to maternal nutrition metabolism. The specific correlation and mechanism is unclear, and there are no effective measures for early diagnosis and treatment. Previous study found that maternal gut microbiota participates in the material metabolism throughout the pregnancy. Insulin sensitivity in pregnant women, and intrauterine environment under abnormal blood glucose and lipid metabolism are important for the gut microbiota of newborns and even they grow up. However, changes in gut microbiota are the cause of the disease or the outcome is not yet clear. Short chain fatty acids (SCFAs) are produced from soluble dietary fibers in the diet by colon bacteriolysis. Studies have found that gut microbiota can regulate insulin sensitivity and glucose and lipid metabolism disorders through SCFAs. Therefore, this research group uses the gut microbiota as a new idea to studythe relationship of gut microbiota characteristics and level's change of SCFAs with glucolipid metabolism and insulin sensitivity in pregnant women with abnormal fetal size and their newborns through 16S-rRNA high-throughput sequencing, pyrosequencing, and gas chromatography-mass spectrometry, so we can reveal the role of gut microbiota in the pathogenesis of abnormal fetal size and explore targeted rational dietary adjustment and SCFAs reconstruction of gut microbiota to improve maternal and neonatal pregnancy outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy

• Term pregnancy with the gestational age of 37-40 weeks

Exclusion Criteria:

• Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)

• Delivery before 37 weeks or after 40 weeks

• Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease)

Related Conditions & MeSH terms

• Fetal Growth Restriction
• Fetal Growth Retardation
• Fetal Macrosomia
• Glucolipid Metabolism
• Gut Microbiota

Intervention

Other:
• test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity
test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers

Locations

Country	Name	City	State
China	department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiota and SCFAs in mothers and their newborns	Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota as well as short chain fatty acids in Stool samples	Stool samples from pregnant women with 37-40 gestational week and newborns within 3 days after birth
Primary	glucolipid metabolism and insulin sensitivity in pregnant women	glucolipid metabolism and insulin sensitivity in pregnant women with normal and abnormal fetal size	Blood samples from pregnant women with 37-40 gestational week