Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection breast milk.
- Who it may be relevant to
- Registry conditions: Breastmilk Collection. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Collection breast milk
Collection of a milk sample taken as part of women's donation
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
France · 1 center
- Lactarium Ile-de-France, Necker-Enfents Malades Hospital — Paris
Identifiers
NCT: NCT06738563 · 2024-017 · 2024-A01159-38