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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04420507
Other study ID # Gut and oral microbiome of GDM
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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)
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