Milk Consumption for Influenza Detection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether drinking pasteurized milk containing safe, inactive particles of the flu virus A(H5) can help detect the virus in the nose or throat. Researchers aim to determine if the body produces antibodies (defense proteins) after consuming this milk, potentially aiding the CDC in improving flu tracking. Participants will be divided into two groups: one will drink the milk once, and the other will drink it for three consecutive days. Ideal participants are healthy individuals without recent respiratory symptoms who can consume pasteurized milk without issues. As an unphased trial, this study offers a unique opportunity to contribute to innovative flu detection research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used influenza antiviral medications in the last 14 days.
What prior data suggests that this method is safe for detecting influenza?
Research shows that pasteurized milk with inactive flu virus particles is under study to assess its impact on flu detection. Past studies have shown that pasteurized dairy products, like milk, contain no live H5N1 virus. This indicates that pasteurization effectively kills the virus, ensuring the milk is safe to drink.
One study found that individuals who repeatedly consumed the virus in pasteurized milk experienced no harmful immune reactions. Additionally, the FDA has tested many pasteurized dairy products and found no live H5N1 virus, confirming the treatment's safety for humans.
Overall, evidence suggests that drinking pasteurized milk with inactive virus particles is generally safe, with no serious side effects reported.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel method for detecting influenza using pasteurized milk containing the A(H5) virus. Unlike traditional diagnostic methods, which often involve nasal swabs or blood tests, this approach could offer a non-invasive and potentially more comfortable alternative. The trial investigates two different protocols: one where participants consume milk for a single day and another over three consecutive days, aiming to determine if this method can reliably indicate influenza presence. If successful, this could revolutionize flu detection by making it simpler and more accessible.
What evidence suggests that consuming A(H5) virus in pasteurized milk could be effective for influenza detection?
This trial will compare two groups: one group will consume 250 mL of pasteurized commercial milk at a single study visit, while the other will consume the same amount for three consecutive days. Studies have shown that pasteurization, which heats milk to kill germs, effectively prevents the H5N1 virus in dairy milk from causing disease. Although the virus's genetic material might remain, it cannot cause illness. Research indicates that even if parts of the virus persist, the risk of infection is eliminated. However, the effects of these remnants on the body's immune system remain unknown. The Centers for Disease Control and Prevention (CDC) aims to understand how drinking this milk might help track flu viruses by observing any immune response in the body.14678
Who Is on the Research Team?
Daniel Graciaa, MD, MPH, MSc
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This study is for individuals who are healthy and interested in helping the CDC understand flu surveillance. Participants should not have any current illness, especially gastroenteritis or influenza, to avoid confusion with the trial's outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume 250 mL of pasteurized milk containing inactive H5N1 virus during a single visit or over three consecutive daily visits
Follow-up
Participants are monitored for influenza detection and adverse events after milk consumption
What Are the Treatments Tested in This Trial?
Interventions
- A(H5) Virus in Pasteurized Milk
Trial Overview
The trial is testing if drinking pasteurized milk containing inactive H5N1 flu virus particles leads to detectable levels of the virus in the nose or throat and if it prompts an antibody response without causing disease.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits.
Participants will consume 250 mL of pasteurized commercial milk at a study visit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Citations
Investigation of Avian Influenza A (H5N1) Virus in Dairy ...
The FDA's ongoing assessments of the milk safety system continue to confirm that pasteurization is effective at eliminating infectious H5N1 virus in dairy milk.
Effectiveness of pasteurization for the inactivation of H5N1 ...
We conclude that pasteurization of milk is an effective strategy for mitigation of the risk of human exposure to milk contaminated with H5N1 virus.
Repeated oral exposure to H5N1 influenza virus in ...
Up to 30% of commercial pasteurized milk tested contained viral genome copies. The impact of residual viral remnants on host immunity is unknown ...
Pasteurisation temperatures effectively inactivate influenza ...
We then show that an H5N1 HPAIV in milk is effectively inactivated by a comparable treatment, even though its genetic material remains ...
Establishing Methods to Monitor Influenza (A)H5N1 Virus ...
Cow milk has emerged as an ideal sample source for H5N1 virus detection and surveillance during this outbreak; the virus is shed in high ...
Influenza A(H5N1) Virus Resilience in Milk after Thermal ...
The effects of pasteurization-like temperatures on influenza viruses in retail and unpasteurized milk revealed virus resilience under certain conditions.
Identification of and Response to Influenza A(H5) in Off-the ...
A(H5N1) virus surveillance of off-the-shelf unpasteurized milk led to early detection and recall of potentially infectious products that prompted state agencies ...
Avian influenza virus type A (H5N1) in U.S. dairy cattle
Highly pathogenic avian influenza (HPAI) was identified in U.S. dairy cattle for the first time in March 2024. Here are important details.
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