An observational study in Breastmilk Collection, sponsored by Institut Pasteur. Recruiting at 1 site in France. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Institut Pasteur · Observational
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.
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.
88 studies on the registry are indexed under Breast Milk Expression; 20 are open to participants now.
This study's planned enrollment of 75 is close to the median of 71 across 36 observational studies indexed under Breast Milk Expression.
Browse Breast Milk Expression studies →Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Breastfeeding adult women who register with the Île-de-France Milk Bank to donate their milk.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
No inclusion criteria:
- Women opposing participation in the study
Exclusion Criteria:
- Positive , , and HTLV serologies (Lactarium exclusion criteria)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactating adult women who donate their milk
Other: Collection breast milk
Collection of a milk sample taken as part of women's donation
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 months
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 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.
Time frame: 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.
Time frame: 36 months
Started Sep 2025 (actual). Primary completion is estimated for Sep 2028, 36 months after the start.
Of 25 observational studies under Breast Milk Expression, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 44. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
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