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Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Primary Purpose

Gestational Diabetes Mellitus, Medical Nutrition Therapy, Overweight/Obese

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prebiotic-containing dairy
Dietary intervention
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.).

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Prebiotic-containing dairy intervention group

Dietary intervention group

Conventional care group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 27, 2019
Last Updated
July 26, 2021
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04190511
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Medical Nutrition Therapy, Overweight/Obese, Gut Microbiota, Adverse Pregnancy Outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prebiotic-containing dairy intervention group
Arm Type
Experimental
Arm Title
Dietary intervention group
Arm Type
Active Comparator
Arm Title
Conventional care group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Prebiotic-containing dairy
Intervention Description
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
Intervention Name(s)
Dietary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of gestational diabetes mellitus
Description
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.
Time Frame
Up to 28 weeks
Title
Weight change during pregnancy
Description
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.
Time Frame
During pregnancy, an average of 38 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.).
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
City
Beijing
State/Province
Chaoyang
ZIP/Postal Code
100026
Country
China

12. IPD Sharing Statement

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Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

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