Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

NCT04190511 | Completed

• 1 other identifier: 2017-KY-015-01
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Prebiotic-containing dairy intervention group

EXPERIMENTAL

Dietary Supplement: Prebiotic-containing dairy; Dietary Supplement: Dietary intervention

Dietary intervention group

ACTIVE COMPARATOR

Dietary Supplement: Dietary intervention

Conventional care group

NO INTERVENTION

Interventions

Prebiotic-containing dairy 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).

Prebiotic-containing dairy intervention group

Dietary intervention 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; Prebiotic-containing dairy intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, Chaoyang, 100026, China

Location

MeSH Terms

Conditions

Diabetes, Gestational; Overweight; Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 9, 2019
• Study Start: December 10, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-07

Locations

CN (1)