Clinical trial NCT04420507: Gut and Oral Microbiome of GDM Patients During Pregnancy
Official title: Different Characteristics of Gut and Oral Microbiota of Women With Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Pregnancy Related
Keywords: Gastrointestinal Microbiome
pregnancy
gestational diabetes mellitus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2020-06-09
Enrollment: 163
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women who can ensure a regular prenatal check in the PUMCH OB clinic.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the gut and oral microbiome of GDM patients during pregnancy
timeFrame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
measure: the gut and oral microbiome of healthy pregnant women
timeFrame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Secondary outcomes:
measure: The glucose level during pregnancy
timeFrame: the first trimester（9-14 gestational weeks), the second trimester (24-28 gestational weeks) and the third trimester(32-37 gestational weeks)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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.
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(Suppl 1):3-17. doi: 10.1111/ijpo.12217. Epub 2017 Apr 26.
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.
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.