Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus; Gut Microbiota; Adverse Pregnancy Outcomes; Medical Nutrition Therapy; Overweight/Obese
• Intervention / Treatment: Dietary supplement: Prebiotic-containing dairy; Dietary supplement: Dietary intervention

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chaoyang
    • Beijing, Chaoyang, China, 100026
      • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prebiotic-containing dairy intervention group	Dietary supplement: 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).; 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.
Active Comparator: Dietary intervention group	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.
No Intervention: Conventional care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of gestational diabetes mellitus	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.	Up to 28 weeks
Weight change during pregnancy	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.	During pregnancy, an average of 38 weeks

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Overweight; Diabetes, Gestational
• Other Study ID Numbers: 2017-KY-015-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No