Breastmilk CollectionBREASTMILKVIRNCT06738563
Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
An observational study of Breastmilk Collection, run by Institut Pasteur at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastmilk Collection
- What is being tested?
- Collection breast milk
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2025to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.
Who may be able to join
- 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
Who cannot join
- Positive HIV, HBV, HCV and HTLV serologies (Lactarium exclusion criteria)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Lactarium Ile-de-France, Necker-Enfents Malades Hospital
Paris, 75015
Virginie RIGOURD, Dr
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 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.
Read the 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.
- Conditions
- Breastmilk Collection
- Being tested
- Collection breast milk
- Keywords
- Milk, Maternal, Virus, Transmission, Infectivity
- Medical subject headings
- Breast Milk Expression, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection breast milkOther
Collection of a milk sample taken as part of women's donation
| Study group | Role | What they receive |
|---|---|---|
| Lactating women | Lactating adult women who donate their milk Receives: Other: Collection breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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).
Measured: 36 months
Secondary outcomes (3)
Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.
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.
Measured: 36 months
Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.
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.
Measured: 36 months
Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start10 Sep 2025
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastmilk CollectionStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Virginie RIGOURD, Dr, Principal investigator, Lactarium Ile-de-France, Necker-Enfents Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738563
- Sponsor's protocol ID
- 2024-017
- Other IDs
- 2024-A01159-38
- Acronym
- BREASTMILKVIR
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
- ClinicalTrials.gov ID
- NCT06738563
- Acronym / sponsor ID
- BREASTMILKVIR / 2024-017
- Conditions
- Breastmilk Collection
- Keywords
- Milk, Maternal, Virus, Transmission, Infectivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactating women | – | Other: Collection breast milkLactating adult women who donate their milk |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.
Key inclusion criteria (6 listed)
- Age > 18 years
- Female gender
- Lactarium Ile-de-France donors
- Subjects covered by a Social Security scheme, excluding State Medical Aid
- Women opposing participation in the study
Key exclusion criteria (1 listed)
- Positive HIV, HBV, HCV and HTLV serologies (Lactarium exclusion criteria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection breast milkCollection of a milk sample taken as part of women's donation | Other | Lactating women |
Primary outcome
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).
3 secondary outcomes
Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.
Time frame: 36 months
Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.
Time frame: 36 months
Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginie RIGOURD, Dr principal investigator
Lactarium Ile-de-France, Necker-Enfents Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastmilk Collection, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore VIDY-ROCHE, PhD (0145688906 ext. +33, aurore.vidy@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.