Gut and Oral Microbiome of GDM Patients During Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes, Pregnancy Related

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM group<br>pregnant women who are diagnosed after 75g OGTT test between 24 27+6 gestational weeks | |
| health group<br>pregnant women who pass the 75g OGTT test and aren't diagnosed as GDM, and also don't have any other conditions, like hypertensive disorders, IBD, gastrointestinal ulcer, and so on. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Microbiome, pregnancy, gestational diabetes mellitus