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NCT Number: NCT06738563

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

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.

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Key information

Conditions

Breastmilk Collection Behavior Breast Feeding Breast Milk Expression Feeding Behavior Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lactarium Ile-de-France, Necker-Enfents Malades Hospital

Paris, 75015, France

Location status: Recruiting

Location contact

Virginie RIGOURD, Dr

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Collection breast milk

Other

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

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.

    Time frame: 36 months

    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).

Secondary outcomes

  1. Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.

    Time frame: 36 months

    The 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.

  2. Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.

    Time frame: 36 months

    Following 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.

  3. Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.

    Time frame: 36 months

    Milk 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore VIDY-ROCHE, PhD

CONTACT

[email protected]

0145688906 ext. +33

Pierre-Emmanuel CECCALDI, PhD

CONTACT

[email protected]

0145688782 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Acronym: BREASTMILKVIR

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Dec 17, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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