Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Capital Medical University

Status

Completed

Conditions

Adverse Pregnancy Outcomes

Gestational Diabetes Mellitus

Gut Microbiota

Overweight/Obese

Medical Nutrition Therapy

Treatments

Dietary Supplement: Dietary intervention

Dietary Supplement: Prebiotic-containing dairy

Study type

Interventional

Funder types

Other

Identifiers

NCT04190511

2017-KY-015-01

Details and patient eligibility

About

Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.

Enrollment

375 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 ~ 45 years
single pregnancy
enrollment week 8-12 + 6 weeks (based on the last menstrual period or B-ultrasound monitoring)
BMI ≥ 25 kg / m2
living in Beijing for at least 5 years

Exclusion criteria

Taking antibiotics, probiotics or prebiotics
smoking regularly
drinking alcohol
assisted fertility technology conception
mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys
history of bariatric surgery
not following dietary recommendations
Lactose intolerance
milk protein allergy
pre-pregnancy hypertension, diabetes, Hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and a history of infectious diseases (hepatitis, tuberculosis, etc.).