Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
ConditionBreastmilk Collection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitut Pasteur
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years
Female gender
Lactarium Ile-de-France donors
Subjects covered by a Social Security scheme, excluding State Medical Aid
Disqualifiers
None
Trial population
Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Collection breast milk
Other interventionCollection of a milk sample taken as part of women's donation
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Lactating women1 intervention
Trial outcomes
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.
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).
Time frame
36 monthsSecondary outcomes
1
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.
Time frame
36 months2
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.
Time frame
36 months3
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.
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov