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

December 8, 2025 updated by: Institut Pasteur

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Lactarium Ile-de-France, Necker-Enfents Malades Hospital
        • Contact:
          • Virginie RIGOURD, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lactating women
Lactating adult women who donate their milk
Other: Collection breast milk
Collection of a milk sample taken as part of women's donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
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.
36 months
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.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Virginie RIGOURD, Dr, Lactarium Ile-de-France, Necker-Enfents Malades Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 17, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-017
  • 2024-A01159-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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