Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
BREASTMILKVIR
2 other identifiers
observational
75
1 country
1
Brief Summary
Exclusive breastfeeding during the first six months of life and continued breastfeeding for at least 24 months constitute the optimal feeding method for infants and young children. However, breast milk and breastfeeding can be significant pathways for the transmission of certain viruses. The objective of this study is to examine the influence of human breast milk and its composition on viral infectivity and viral transmission of the HTLV-1 virus and arboviruses such as Zika virus, yellow fever, dengue, and tick-borne encephalitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2025
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2024
CompletedFirst Posted
Study publicly available on registry
December 17, 2024
CompletedStudy Start
First participant enrolled
September 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
December 15, 2025
December 1, 2024
3 years
December 4, 2024
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study the influence of breast milk and its composition on viral infectivity and oral transmission of HTLV-1 and arboviruses such as Zika virus, yellow fever virus, dengue virus, and tick-borne encephalitis virus.
Various viruses will be incubated with milk samples. The influence of milk on the different viruses will be studied. The capacity of these viruses incubated with milk to infect the target cells (immune or epithelial cells, depending on the virus) will be measured (measurement of the number of infected cells).
36 months
Secondary Outcomes (3)
Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.
36 months
Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.
36 months
Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.
36 months
Study Arms (1)
Lactating women
Lactating adult women who donate their milk
Interventions
Collection of a milk sample taken as part of women's donation
Eligibility Criteria
Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.
You may qualify if:
- Age \> 18 years
- Female gender
- Lactarium Ile-de-France donors
- Subjects covered by a Social Security scheme, excluding State Medical Aid
- \- Women opposing participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
Study Sites (1)
Lactarium Ile-de-France, Necker-Enfents Malades Hospital
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Virginie RIGOURD, Dr
Lactarium Ile-de-France, Necker-Enfents Malades Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2024
First Posted
December 17, 2024
Study Start
September 10, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2030
Last Updated
December 15, 2025
Record last verified: 2024-12