Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus; Adverse Pregnancy Outcomes; Medical Nutrition Therapy; Overweight/Obese; Gut Microbiota
• Interventions: Dietary Supplement: Dietary intervention; Dietary Supplement: Prebiotic-containing dairy

• Registration Number: NCT04190511
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-09
• Study Start: 2019-12-10
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 375

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary intervention group	Dietary intervention	-
Prebiotic-containing dairy intervention group	Prebiotic-containing dairy	-
Prebiotic-containing dairy intervention group	Dietary intervention	-

Primary Outcome Measures

Name	Time	Method
The incidence of gestational diabetes mellitus	Up to 28 weeks	The diagnose of GDM based on the result of OGTT according to IADPSG criterion in 24 to 28 weeks. We will compare the incidence of GDM in these three groups.
Weight change during pregnancy	During pregnancy, an average of 38 weeks	We asked pregnant woman to weigh their weight using the same weighing scale in the morning of the inspection day after urinating and tell the obstetrician to record. Compare the weight gain during pregnancy among three groups.

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University; 🇨🇳 Beijing, Chaoyang, China