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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03633162
Other study ID # 2018041801
Secondary ID 8167318120150803
Status Recruiting
Phase
First received
Last updated
Start date May 21, 2018
Est. completion date December 31, 2038

Study information

Verified date September 2023
Source Guangzhou Women and Children's Medical Center
Contact Xiu Qiu, PhD
Phone 0086 20 38367160
Email qxiu0161@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The MGBIG is a study exploring cross-generational effects in 5000 women and their children and grandchildren located in Guangzhou, China. Its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology and on explaining the cause of the disease from the perspective of "grandmother-mother-child" heredity. Data are collected regarding environmental exposures, lifestyle, and social support on grandmother from birth to old age. Biological samples including blood and tissue samples are collected.


Description:

It was previously believed that heredity strictly follows Mendel's laws, but recent studies have found that through placental material exchange, mammals may transfer maternal immune-related factors vertically, thus promoting the protection of "non-heredited maternal antigenic traits". Thus, the transmission of reproductive information across generations is realized. Since the unusual genetic pattern of the X chromosome, grandmother's influence may be gender specific. Since grandchildren were usually took care by grandparents in China, it could be achievable to attach and recruit maternal grandmother together with mother and children. Cohort including three generations of women is rare in Asia at present. In the MGBIG, extensive information including demographic characteristics, lifestyle, history of diseases, mental health, and behaviors is collected from the participants. Longitudinal follow up and surveillance of common chronic diseases are also to be conducted. The MGBIG intends to recruit maternal grandmothers to study the effects of maternal genetic and environmental exposure on the health of their children and grandchildren.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 31, 2038
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 36 Years to 100 Years
Eligibility Inclusion Criteria: 1. Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's Medical Center 2. Baseline information of maternal grandmother's daughter during pregnancy available Exclusion Criteria: 1. Significant cardiovascular abnormalities 2. Intelligent obstacle, intellectual disabilities or gawkish condition

Study Design


Locations

Country Name City State
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong

Sponsors (3)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center Children's Hospital Medical Center, Cincinnati, University of Birmingham

Country where clinical trial is conducted

China, 

References & Publications (2)

Kinder JM, Jiang TT, Ertelt JM, Xin L, Strong BS, Shaaban AF, Way SS. Cross-Generational Reproductive Fitness Enforced by Microchimeric Maternal Cells. Cell. 2015 Jul 30;162(3):505-15. doi: 10.1016/j.cell.2015.07.006. Epub 2015 Jul 23. — View Citation

Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Haplotypes transfered by non-inherited maternal antigens from maternal grandmother to female offspring Assessed by analyses of MHC haplotypes, HLA haplotypes, and levels of non-inherited maternal antigens of mother and offspring, and pregnancy complication of maternal grandmothers and mothers From the date of her daughter get pregnant until the date her grandchild/grandchildren is/are given birth
Secondary Serum levels of Inflammatory factors at grandchildren's birth and early neonatal life Assessed by analyses of IL-1, IL-6, IL-10, IL-12, etc. At the birth date of her grandchild/grandchildren, at the date 42 days after the birth of the certain grandchild/grandchildren
Secondary The prevalence of eczema of grandchildren Assessed by self-reported time of onset and electronic medical record At the age of 6 weeks, 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Secondary The incidence of asthma of grandchildren Assessed by self-reported time of onset and electronic medical record At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Secondary The prevalence of Allergic rhinitis of grandchildren Assessed by self-reported time of onset and electronic medical record At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Secondary The prevalence of Food allergy of children and grandchildren Assessed by self-reported time of onset and electronic medical record At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years of grandchildren
Secondary Changes of body composition of grandchildren Body composition is assessed using Dual Energy X-Ray Absorptiometry At age of 3 years,6 years, 12years and 18years
Secondary Changes of bone density of grandchildren Bone density is assessed using Dual Energy X-Ray Absorptiometry At age of 3 years,6 years, 12years and 18years
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