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

Trial Summary

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.

Is it safe to consume milk for influenza detection?

Research shows that consuming unpasteurized milk can pose health risks, including outbreaks of illnesses caused by bacteria like E. coli, Salmonella, and Campylobacter. Pasteurized milk is generally safer, but there have been cases of contamination after pasteurization, indicating potential risks. ^{1 2 3 4 5}

How does the treatment A(H5) Virus in Pasteurized Milk differ from other treatments for influenza?

The treatment using A(H5) Virus in Pasteurized Milk is unique because it involves administering the virus through pasteurized milk, which is a novel route compared to traditional vaccines or antiviral drugs. This approach may offer a more accessible and potentially safer method of delivering the virus for detection or immune response, as pasteurized milk has a low prevalence of harmful bacteria. ^{3 4 5 6 7}

What is the purpose of this trial?

The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat. Inactive particles are not capable of causing disease. The results will help the Centers for Disease Control and Prevention (CDC) better understand how milk consumption could affect flu surveillance. Investigators also want to see if the body produces antibodies in response to this milk consumption.

Research Team

Daniel Graciaa, MD, MPH, MSc

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

An outbreak of Cryptosporidium parvum linked to pasteurised milk from a vending machine in England: a descriptive study, March 2021. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Campylobacter outbreak associated with raw drinking milk, North West England, 2016. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Microbiological quality of raw drinking milk and unpasteurised dairy products: results from England 2013-2019. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Outbreak of Escherichia coli O157:H7 associated with raw milk consumption in the Pacific Northwest. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Outbreak-Related Disease Burden Associated with Consumption of Unpasteurized Cow's Milk and Cheese, United States, 2009-2014. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Human Campylobacter infection associated with certified raw milk. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Comprehensive survey of pasteurized fluid milk produced in the United States reveals a low prevalence of Listeria monocytogenes. [2023]