Drinking fermented milk containing probiotics and postbiotics on COVID vaccine response

Phase 2

Completed

• Conditions: Healthy adult individuals; SARs-CoV2; probiotics; postbiotics; immune response; vaccine

• Registration Number: TCTR20240630005
• Lead Sponsor: Institute of Nutrition, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-06-14
• Study Start: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. Age 20-59 years old, 2. Body mass index less than 30 kg per square meter, 3. No systemic diseases, 4. Normal blood result (in 6 months) with hemoglobin between 11-16 grams per decilitre for females, 12-18 grams per decilitre for males, WBC 4,000 to 10,000 cells per cubic meter, fasting plasma glucose no more than 125 milligrams per decilitre, total cholesterol to HDL ratio no more than 5 to 1, ALT no more than 60 Units per liter, eGFR at least 90 milligrams per millimole, 5. having an appointment for boosting the dose of vaccination, i.e. BNT162b2 (Pfizer) or mRNA-1273 (Moderna) at least 1 week ahead or having no schedules for boosting vaccination but receiving the last vaccination for more than 3 months, 6. able to continuously consume fermented milk for 4 weeks

Exclusion Criteria

1. Pregnant, 2. Breastfeeding, 3. Bleeding problems e.g. idiopathic thrombocytopenia, 4. COVID-19 infection, 5. Severe food allergy (Anaphylaxis), 6. High risk of COVID-19 infection, 7. During participation in other projects with blood collection, drugs, herbs, or dietary supplements, 8. Unable to refrain from probiotics, e.g. drinking fermented milk, yogurt, cheese, kimchi, 9. Receiving antibiotics during the study, 10. Smoking at least 5 cigarettes per day, 11. Alcohol drinking at least 14 standard drinks (1 drink = 1 pint of liquor = 1 small bottle of beer = 1 glass of wine)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
total antibodies to SARS-CoV-2 baseline, before vaccination, 4 weeks, 8 weeks and 12 weeks after vaccination ELISA ,functional antibodies to SARS-CoV-2 baseline, before vaccination, 4 weeks, 8 weeks and 12 weeks after vaccination FRNT

Secondary Outcome Measures

Name	Time	Method
adverse symptoms baseline, before vaccination, 4 weeks, 8 weeks and 12 weeks after vaccination subject diary and interviews