Clinical trial NCT04190511: Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy
Official title: Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Medical Nutrition Therapy
Overweight/Obese
Gut Microbiota
Adverse Pregnancy Outcomes
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: The incidence of gestational diabetes mellitus
timeFrame: Up to 28 weeks
measure: Weight change during pregnancy
timeFrame: During pregnancy, an average of 38 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital,Capital Medical University
state: Chaoyang
Study officials:
References: