Gut and Oral Microbiome of GDM Patients During Pregnancy

Pregnancy Related Clinical Trial

Official title:

Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420507
• Other study ID #: Gut and oral microbiome of GDM
• Status: Completed
• Start date: May 15, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aimed to clarify the characteristics of the intestinal and oral microbiome of Gestational Diabetes Mellitus(GDM) patients during the whole pregnancy, try to clarify the relationship between the microbiome and GDM.

Description:

The aims of the study are to reveal the possibly natural change of the gut and oral microbiome of GDM patients during pregnancy, and to explorer whether GDM happened during pregnancy are associated with the maternal gut and oral microbiomes. As a perspective cohort study, the researchers will recruit pregnant women in early pregnancy（before 13 gestational weeks）and following the pregnancies till delivery. The stool samples and saliva samples of the recruits will be collected in 9~14,24~28 and 32~37 gestational weeks separately. The investigators will also perform oral examination between 24~28 weeks and sample subgingival plaque for test. Overall, all samples will be examined use 16S rRNA gene sequencing to analyze microbiome. And part of the samples of GDM patients will be analyzed using metagenomics. Combine with the pregnancy outcomes, the differences of gut and oral microbiome between GDM patients and healthy women will be expected, as well as the natural change during pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant women

• gestational age: before 13+6 weeks

• regular prenatal care in PUMCH

Exclusion Criteria:

• have medical history or current conditions: Gastrointestinal disorders, for example:

Gastritis, gastric ulcer, inflammatory bowel disease; Hypertension; Diabetes; SLE or other severe CTD;

• pregnant, combine with malignancy diseases;

• pregnant, can't ensure regular prenatal check.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy Related

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (4)

Edwards SM, Cunningham SA, Dunlop AL, Corwin EJ. The Maternal Gut Microbiome During Pregnancy. MCN Am J Matern Child Nurs. 2017 Nov/Dec;42(6):310-317. doi: 10.1097/NMC.0000000000000372. — View Citation

Jordan S, Baker B, Dunn A, Edwards S, Ferranti E, Mutic AD, Yang I, Rodriguez J. Maternal-Child Microbiome: Specimen Collection, Storage, and Implications for Research and Practice. Nurs Res. 2017 Mar/Apr;66(2):175-183. doi: 10.1097/NNR.0000000000000201. — View Citation

Sharon G, Sampson TR, Geschwind DH, Mazmanian SK. The Central Nervous System and the Gut Microbiome. Cell. 2016 Nov 3;167(4):915-932. doi: 10.1016/j.cell.2016.10.027. Review. — View Citation

Walker RW, Clemente JC, Peter I, Loos RJF. The prenatal gut microbiome: are we colonized with bacteria in utero? Pediatr Obes. 2017 Aug;12 Suppl 1:3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the gut and oral microbiome of GDM patients during pregnancy	The composition and species of gut and oral microbiome of GDM patients,separately in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).	the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Primary	the gut and oral microbiome of healthy pregnant women	The composition and species of gut and oral microbiome of healthy pregnant women ,separately in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks).	the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Secondary	The glucose level during pregnancy	The fasting blood glucose level and the glycosylated albumin level in the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks). And the result of 75gOGTT test.	the first trimester(9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)