Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

How breast milk affects virus infectivity and transmission

Official title: Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"

Run by Institut Pasteur · NCT06738563 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment75 (estimated)
SponsorInstitut Pasteur
Industry-sponsored
Locations1 site (Paris)
StatusRecruiting
StartedSeptember 10, 2025
Main results expectedSeptember 2028
Study endsSeptember 2030
Registry record updatedDecember 15, 2025
Trial IDNCT06738563 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.