- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03633162
Maternal Grandmothers in the Born in Guangzhou Cohort Study (MGBIG)
September 11, 2023 updated by: Xiu Qiu, Guangzhou Women and Children's Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiu Qiu, PhD
- Phone Number: 0086 20 38367160
- Email: qxiu0161@163.com
Study Contact Backup
- Name: Xueling Wei, MS
- Phone Number: 0086 20 38367159
- Email: xueling.wei@bigcs.org
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510623
- Recruiting
- Guangzhou Women and Children's Medical Center
-
Contact:
- Xiu Qiu, Doctor
- Phone Number: +862038076001
- Email: qxiu0161@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
All maternal grandmothers of the children in the Born in Guangzhou Cohort Study (BIGCS) would be recruited.
Description
Inclusion Criteria:
- Maternal Grandmother' grandchildren delivered in Guangzhou Women and Children's Medical Center
- Baseline information of maternal grandmother's daughter during pregnancy available
Exclusion Criteria:
- Significant cardiovascular abnormalities
- Intelligent obstacle, intellectual disabilities or gawkish condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Haplotypes transfered by non-inherited maternal antigens from maternal grandmother to female offspring
Time Frame: From the date of her daughter get pregnant until the date her grandchild/grandchildren is/are given birth
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum levels of Inflammatory factors at grandchildren's birth and early neonatal life
Time Frame: At the birth date of her grandchild/grandchildren, at the date 42 days after the birth of the certain grandchild/grandchildren
|
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
|
The prevalence of eczema of grandchildren
Time Frame: At the age of 6 weeks, 6 months, 1year, 3 years, 6 years, 12years and 18years 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
|
The incidence of asthma of grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years 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
|
The prevalence of Allergic rhinitis of grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years 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
|
The prevalence of Food allergy of children and grandchildren
Time Frame: At the age of 6 months, 1year, 3 years, 6 years, 12years and 18years 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
|
Changes of body composition of grandchildren
Time Frame: At age of 3 years,6 years, 12years and 18years
|
Body composition is assessed using Dual Energy X-Ray Absorptiometry
|
At age of 3 years,6 years, 12years and 18years
|
Changes of bone density of grandchildren
Time Frame: At age of 3 years,6 years, 12years and 18years
|
Bone density is assessed using Dual Energy X-Ray Absorptiometry
|
At age of 3 years,6 years, 12years and 18years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiu Qiu, PhD, Guangzhou Women and Children's Medical Center, China
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2018
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2038
Study Registration Dates
First Submitted
July 23, 2018
First Submitted That Met QC Criteria
August 13, 2018
First Posted (Actual)
August 16, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 11, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018041801
- 81673181 (Other Grant/Funding Number: National Natural Science Foundation of China)
- 201508030037 (Other Grant/Funding Number: Guangzhou Science and Technology Bureau, Guangzhou, China)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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