Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

NCT ID: NCT04190511

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2020-12-31

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.

Conditions

Gestational Diabetes Mellitus; Medical Nutrition Therapy; Overweight/Obese; Gut Microbiota; Adverse Pregnancy Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Prebiotic-containing dairy intervention group

Group Type: EXPERIMENTAL

Prebiotic-containing dairy

Intervention Type: DIETARY_SUPPLEMENT

The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).

Dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.

Dietary intervention group

Group Type: ACTIVE_COMPARATOR

Dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.

Conventional care group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prebiotic-containing dairy

The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).

Intervention Type: DIETARY_SUPPLEMENT

Dietary intervention

The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.

Intervention Type: DIETARY_SUPPLEMENT

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Guanghui Li

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, Chaoyang, China

Countries

China

Other Identifiers

2017-KY-015-01

Identifier Type: -

Identifier Source: org_study_id