How breast milk affects virus infectivity and transmission
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Institut Pasteur · NCT06738563
This project will test whether components of donated breast milk change how viruses such as HTLV-1, Zika, dengue, yellow fever, and tick-borne encephalitis infect cells and could affect transmission.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Pasteur (industry) |
| Locations | 1 site (Paris) |
| Trial ID | NCT06738563 on ClinicalTrials.gov |
What this trial studies
This observational effort collects breast milk donated to the Lactarium Île-de-France and analyzes its composition and antiviral effects. Eligible adult donors who are seronegative for HIV, HBV, HCV, and HTLV provide milk samples that are processed for biochemical analysis and laboratory infection assays. In vitro studies will measure how milk and specific milk components influence viral infectivity and potential transmission for HTLV-1 and selected arboviruses. Samples are handled in virology laboratories at Institut Pasteur and associated hospital sites with no intervention beyond routine milk donation procedures.
Who should consider this trial
Good fit: Ideal candidates are lactating women over 18 who donate to the Lactarium Île-de-France, are covered by French social security, and test negative for HIV, HBV, HCV, and HTLV.
Not a fit: Women who are HIV, HBV, HCV, or HTLV positive, persons who are not Lactarium donors, or non-lactating individuals are not eligible and are unlikely to benefit directly from participation.
Why it matters
Potential benefit: If successful, the work could identify milk components that block or enhance viral infectivity, informing safer milk-banking practices and breastfeeding guidance in virus-endemic settings.
How similar studies have performed: Previous studies have shown breast milk can transmit HTLV-1, HIV, and CMV, while the role of breast milk in arbovirus transmission (Zika, dengue, yellow fever, TBE) is less well characterized and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Female gender * Lactarium Ile-de-France donors * Subjects covered by a Social Security scheme, excluding State Medical Aid No inclusion criteria: \- Women opposing participation in the study Exclusion Criteria: \- Positive HIV, HBV, HCV and HTLV serologies (Lactarium exclusion criteria)
Where this trial is running
Paris
- Lactarium Ile-de-France, Necker-Enfents Malades Hospital — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Virginie RIGOURD, Dr — Lactarium Ile-de-France, Necker-Enfents Malades Hospital
- Study coordinator: Aurore VIDY-ROCHE, PhD
- Email: aurore.vidy@pasteur.fr
- Phone: 0145688906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breastmilk Collection, Milk, Maternal, Virus, Transmission, Infectivity