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Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190511
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : January 30, 2020
Sponsor:
Information provided by (Responsible Party):
Guanghui Li, 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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Medical Nutrition Therapy Overweight/Obese Gut Microbiota Adverse Pregnancy Outcomes Dietary Supplement: Prebiotic-containing dairy Dietary Supplement: Dietary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The incidence of gestational diabetes mellitus [ Time Frame: 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.

  2. Weight change during pregnancy [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190511


Locations
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China, Chaoyang
Beijing Obstetrics and Gynecology Hospital,Capital Medical University Recruiting
Beijing, Chaoyang, China, 100026
Contact: Guanghui Li, MD, PhD    86-13811830756    liguanghui2007@163.com   
Sponsors and Collaborators
Capital Medical University
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Responsible Party: Guanghui Li, Professor, MD, PhD, Capital Medical University
ClinicalTrials.gov Identifier: NCT04190511    
Other Study ID Numbers: 2017-KY-015-01
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Overweight
Body Weight
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases