Milk Consumption for Influenza Detection

Overseen By Daniel Graciaa, MD, MPH, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Influenza antivirals, Immunosuppressants

Disqualifiers: Respiratory illness, Immunosuppression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1-3 days

30 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

I understand English, can give consent, and can follow the study plan.

BMI ≤ 35 kg/m2

In good general health based on medical history and the investigator's clinical judgment

Exclusion Criteria

I have taken flu medication in the last 14 days.

Current pregnancy or breastfeeding

History of allergy or intolerance to milk or milk alternatives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume 250 mL of pasteurized milk containing inactive H5N1 virus during a single visit or over three consecutive daily visits

1-3 days

1 visit (in-person) or 3 visits (in-person)

Follow-up

Participants are monitored for influenza detection and adverse events after milk consumption

30 days

2 visits (in-person) for a subset of participants

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?

Group I: 3-Day Group Experimental Treatment 1 Intervention

Participants will consume 250 mL of pasteurized commercial milk for a total of 3 daily consecutive visits.

Group II: 1-Day Group Experimental Treatment 1 Intervention

Participants will consume 250 mL of pasteurized commercial milk at a study visit.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. fda.gov fda.gov/food/alerts-advisories-safety-information/investigation-avian-influenza-h5n1-virus-dairy-cattle

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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740002024001916

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12466813/

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 ...

4. nature.com nature.com/articles/s41467-025-56406-8

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 ...

5. wwwnc.cdc.gov wwwnc.cdc.gov/eid/article/31/13/25-0087_article

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 ...

6. wwwnc.cdc.gov wwwnc.cdc.gov/eid/article/30/11/24-0772_article

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.

7. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf420/8221962

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 ...

8. avma.org avma.org/resources-tools/animal-health-and-welfare/animal-health/avian-influenza/avian-influenza-virus-type-h5n1-us-dairy-cattle

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.