Clinical trial NCT06738563: Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Official title: Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breastmilk Collection
Keywords: Milk
Maternal
Virus
Transmission
Infectivity
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.

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.

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)

Primary outcomes:
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.
timeFrame: 36 months
Secondary outcomes:
measure: Determine the antiviral or proviral mechanisms of certain biological factors in breast milk.
timeFrame: 36 months
measure: Determine the role of breast milk in the mechanisms by which the relevant viruses cross an epithelium.
timeFrame: 36 months
measure: Determine the influence of a few hours of incubation at 4°C (refrigeration) on the previously mentioned mechanisms.
timeFrame: 36 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Lactarium Ile-de-France, Necker-Enfents Malades Hospital
Study officials:
affiliation: Lactarium Ile-de-France, Necker-Enfents Malades Hospital
name: Virginie RIGOURD, Dr
role: PRINCIPAL_INVESTIGATOR
References: