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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05250219
Other study ID # RECHMPL21_0724
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2022

Study information

Verified date February 2022
Source University Hospital, Montpellier
Contact Franck PELLESTOR, MD PHD
Phone 06.29.04.83.18
Email f-pellestor@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender Male
Age group 1 Year to 16 Years
Eligibility Inclusion criteria: - age 1-16 years (at the time of surgery) - male - known breastfeeding status in infancy Exclusion criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uh Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. day 1
Primary 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. day 1
Primary to determine Quantifying the microchimeric cells Quantifying the microchimeric cells : Cell quantification will be assessed through FISH staining (automated cell counting) and qPCR day 1
Primary 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 day 1
Primary 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 day 1
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