Gut MicrobiomeNCT04117321
Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
An observational study of Gut Microbiome and Mother to Child Transmission, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiome, Mother to Child Transmission
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2019to 2 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This project will consist of a total 100,000 mother-baby pairs from all centers in 7 years. The study is exploratory in nature. In considering the number of events required for reliable quantification of different factors on a range of diseases, we decided to include 100,000 mother-baby pairs.
Who may be able to join
- Being pregnant
- Plan to give birth in local hospital
- Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent)
- Plan to stay in the same local area for at least 7 years post-delivery Exclusion Criteria: No
- New Born Baby Inclusion Criteria
- Be a new born baby of an enrolled pregnant woman
Show all 10Show fewer
- One of the parents or legal guardian is competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No
- Father of new born baby Inclusion Criteria
- Biological father of an enrolled new born baby
- Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent) Exclusion Criteria: No
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Hong Kong
Francis KL Chan, MD, 85226323143
About this study
The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function. Dysbiosis of gut microbiota has been linked with obesity, hyperglycemia, hyperlipidemia, inflammatory bowel disease and other chronic inflammatory diseases. Gut microbiota is affected by host genetic markup, diet and life style; and therefore varied by human races and geographical locations.
The development of gut microbiota starts before birth. The infant's microbiome can impact on human health in later life. The microbiome of pregnant women are associated with early-life microbiota of their offspring as well as growth, neurodevelopment and the development of allergic and neurocognitive disorders.
Early childhood, when the microbiota is less mature and more malleable, is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed.
- Conditions
- Gut Microbiome, Mother to Child Transmission
- Keywords
- Mommy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women who are being pregnant and plan to give birth in local hospital. Pregnant women who plan to stay in the same local area for at least 7 years post-delivery. | |
| New Born Baby | new born baby of an enrolled pregnant woman. | |
| Father of new born baby | Biological father of an enrolled new born baby. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a 100,000 pair of mother-baby longitudinal cohort
Set up a large scale database to collect data such as comprehensive clinical data, such as mother's and father's demographic and clinical information (e.g. age, weight, gender, family medical history, dietary, drug usage etc.)
Measured: 8 year
Secondary outcomes (2)
Dissect the important microbiome that maintain health
Study samples will be collected to characterize which microbiota will be transmitted from mother to baby by performing metagenomics of gut microbiome in stool and other samples
Measured: 8 year
Seize the golden period of early life for prevention of human diseases
Study samples will be collected to characterize which microbiota induces disease by performing metagenomics of gut microbiome in stool and other samples and develop treatment with microbiota.
Measured: 8 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start23 Sep 2019
- Primary completion2 Oct 2026 (estimated)
- Study completion2 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis KL Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117321
- Sponsor's protocol ID
- MOMmy study
- Status last verified
- May 2024
- First submitted
- 3 Oct 2019
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother-infant Microbiota Transmission and Its Link to the Health of the Baby
- ClinicalTrials.gov ID
- NCT04117321
- Acronym / sponsor ID
- MOMmy study
- Conditions
- Gut Microbiome, Mother to Child Transmission
- Keywords
- Mommy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 2 Oct 2026 (estimated)
- Study completion
- 2 Oct 2027 (estimated)
- First posted
- 7 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human intestinal tract harbors a diverse and complex microbial community, known as gut microbiota, which is critical in sustaining physiology, metabolism, nutrition and immune function. Dysbiosis of gut microbiota has been linked with obesity, hyperglycemia, hyperlipidemia, inflammatory bowel disease and other chronic inflammatory diseases. Gut microbiota is affected by host genetic markup, diet and life style; and therefore varied by human races and geographical locations.
The development of gut microbiota starts before birth. The infant's microbiome can impact on human health in later life. The microbiome of pregnant women are associated with early-life microbiota of their offspring as well as growth, neurodevelopment and the development of allergic and neurocognitive disorders.
Early childhood, when the microbiota is less mature and more malleable, is a golden age for microbiota manipulation to prevent disease. Studying microbiota at this golden age also allow us to dissect the development of a faulty microbiota and identify therapeutic targets to reverse it and cure diseases that are already developed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Women who are being pregnant and plan to give birth in local hospital. Pregnant women who plan to stay in the same local area for at least 7 years post-delivery. |
| New Born Baby | – | –new born baby of an enrolled pregnant woman. |
| Father of new born baby | – | –Biological father of an enrolled new born baby. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This project will consist of a total 100,000 mother-baby pairs from all centers in 7 years. The study is exploratory in nature. In considering the number of events required for reliable quantification of different factors on a range of diseases, we decided to include 100,000 mother-baby pairs.
Key inclusion criteria (10 listed)
- Being pregnant
- Plan to give birth in local hospital
- Competent to provide informed consent (no mental illness or dementia, etc. that will hinder their ability to undertake informed consent)
- Plan to stay in the same local area for at least 7 years post-delivery Exclusion Criteria: No
- New Born Baby Inclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a 100,000 pair of mother-baby longitudinal cohort
Time frame: 8 year
Set up a large scale database to collect data such as comprehensive clinical data, such as mother's and father's demographic and clinical information (e.g. age, weight, gender, family medical history, dietary, drug usage etc.)
2 secondary outcomes
Dissect the important microbiome that maintain health
Time frame: 8 year
Seize the golden period of early life for prevention of human diseases
Time frame: 8 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiome and Mother to Child Transmission, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Ching (+852 26373260, jessicaching@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a 100,000 pair of mother-baby longitudinal cohort (time frame: 8 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.