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Impact of Breast Milk on the Infectivity and Transmission of Different Viruses BREASTMILKVIR

Impact of Breast Milk on the Infectivity and Transmission of Different Viruses BREASTMILKVIR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06738563
Acronym
BREASTMILKVIR
Enrollment
75
Registered
2024-12-17
Start date
2025-09-10
Completion date
2030-09-30
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastmilk Collection

Keywords

Milk, Maternal, Virus, Transmission, Infectivity

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.

Detailed description

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 at least three human viruses: HTLV-1, HIV, and human cytomegalovirus (CMV). To address the following main objective: to study 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.The study plans to collect milk samples from lactating women who are registered with the Lactarium of Île-de-France to donate their breast milk.

Interventions

OTHERCollection breast milk

Collection of a milk sample taken as part of women's donation

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.36 monthsVarious 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).

Secondary

MeasureTime frameDescription
Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.36 monthsThe level of proteins, carbohydrates and fatty acids will be measured in the milk using an infrared spectrometer. The aim is to find out whether the composition of the milk can influence its antiviral or proviral mechanisms.
Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.36 monthsFollowing the addition of viral particles or infected cells to the apical side of an in vitro intestinal model, the impact of breastmilk on crossing efficacy and underlying mechanisms will be assessed. Measurement of the number of viruses that cross the barrier of the intestinal epithelium in the presence of milk by comparing the number of viruses that cross the barrier of the intestinal epithelium without being incubated with milk.
Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.36 monthsMilk samples will be incubated at 4°C. It has been demonstrated for several enveloped viruses, including the Zika virus, that refrigeration of breast milk (4°C) induces an antiviral effect. However, some experiments seem to indicate major differences in the kinetics of this effect, depending on milk factors. Kinetics will be measured.

Countries

France

Contacts

Primary ContactAurore VIDY-ROCHE, PhD
aurore.vidy@pasteur.fr0145688906
Backup ContactPierre-Emmanuel CECCALDI, PhD
pierre-emmanuel.ceccaldi@pasteur.fr0145688782

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026