BreastfeedingNCT05250219
Microchimeric Cell Tranfer From Mother to Child - Pilo Study
An observational study of Breastfeeding, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding. Read more about this study
- Who is it for?
- Ages 1 year to 16 years, men only
- Conditions the study is for
- Breastfeeding
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 16 years
- Men only
- No healthy volunteers
- Child
Study population: Young males, undergoing surgery (appendectomy ou tonsillectomy) for medical reasons
Who may be able to join
- age 1-16 years (at the time of surgery)
- male
- known breastfeeding status in infancy
Who cannot join
- premature birth (before 37 weeks)
- history of blood transfusion
- history of bone marrow transplant
- history of organ transplant
- patient known to have a twin
- known gonosomal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34280
Boris DMITRENKO, 06.29.04.83.18 ext. 33, b-dmitrenko@chu-montpellier.fr
Franck PELLESTOR
About this study
Official title: Identifying and Quantifying Microchimeric Maternal Cells in Young Males, Potentially Acquired Through Breastfeeding - A Pilot Study
Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding.
This study is designed to analyse lymphoid and digestive tract tissues (tonsils and appendixes) in male infants (or young adults) to research microchimeric female cells and try to correlate the frequency and localisation of said cells to the breastfeeding status during early infancy
- Conditions
- Breastfeeding
- Keywords
- Microchimeric, Microchimerism
- Medical subject headings
- Breast Feeding
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 |
|---|---|---|
| patients for tonsils | 40 patients for tonsils | |
| patients for appendixes | 40 patients for appendixes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify microchimeric cells of maternal origin in lymphoid
To identify microchimeric cells of maternal origin in lymphoid in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.
Measured: day 1
To identify microchimeric cells of maternal origin in digestive tissues
To identify microchimeric cells of maternal origin in digestive tissues in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.
Measured: day 1
to determine Quantifying the microchimeric cells
Quantifying the microchimeric cells : Cell quantification will be assessed through FISH staining (automated cell counting) and qPCR
Measured: day 1
to determine locating the cells in tissues
locating the cells in tissues : Appendix histology slides will be analysed after FISH staining to locate the microchimeric cells
Measured: day 1
to determine trying to find a correlation between breastfeeding status
trying to find a correlation between breastfeeding status : Microchimeric cell quantification will be confronted to the breastfeeding status in infancy (collected during patient inclusion) to validate a correlation
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Sep 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris DMITRENKO, Study director, UH MONTPELLIER - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250219
- Sponsor's protocol ID
- RECHMPL21_0724
- Status last verified
- Feb 2022
- First submitted
- 24 Dec 2018
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Quantifying Microchimeric Maternal Cells in Young Males, Potentially Acquired Through Breastfeeding - A Pilot Study
- ClinicalTrials.gov ID
- NCT05250219
- Acronym / sponsor ID
- RECHMPL21_0724
- Conditions
- Breastfeeding
- Keywords
- Microchimeric, Microchimerism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Feb 2022 (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.
Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding.
This study is designed to analyse lymphoid and digestive tract tissues (tonsils and appendixes) in male infants (or young adults) to research microchimeric female cells and try to correlate the frequency and localisation of said cells to the breastfeeding status during early infancy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients for tonsils | – | –40 patients for tonsils |
| patients for appendixes | – | –40 patients for appendixes) |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young males, undergoing surgery (appendectomy ou tonsillectomy) for medical reasons
Key inclusion criteria (3 listed)
- age 1-16 years (at the time of surgery)
- male
- known breastfeeding status in infancy
Key exclusion criteria (6 listed)
- premature birth (before 37 weeks)
- history of blood transfusion
- history of bone marrow transplant
- history of organ transplant
- patient known to have a twin
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
To identify microchimeric cells of maternal origin in lymphoid
Time frame: day 1
To identify microchimeric cells of maternal origin in lymphoid in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.
To identify microchimeric cells of maternal origin in digestive tissues
Time frame: day 1
To identify microchimeric cells of maternal origin in digestive tissues in young males cytogenetic FISH staining, coupled with MS-PCR, to identify microchimeric cells.
to determine Quantifying the microchimeric cells
Time frame: day 1
Quantifying the microchimeric cells : Cell quantification will be assessed through FISH staining (automated cell counting) and qPCR
to determine locating the cells in tissues
Time frame: day 1
locating the cells in tissues : Appendix histology slides will be analysed after FISH staining to locate the microchimeric cells
to determine trying to find a correlation between breastfeeding status
Time frame: day 1
trying to find a correlation between breastfeeding status : Microchimeric cell quantification will be confronted to the breastfeeding status in infancy (collected during patient inclusion) to validate a correlation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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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. This study is not recruiting at the moment.
Boris DMITRENKO study director
UH MONTPELLIER - FRANCE
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 Breastfeeding, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Feb 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franck PELLESTOR, MD PHD (06.29.04.83.18 ext. 33, f-pellestor@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify microchimeric cells of maternal origin in lymphoid (time frame: day 1). The study lists 5 primary outcomes in all. 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 22 Feb 2022.