Drinking fermented milk containing probiotics and postbiotics on COVID vaccine response

Efficacy study of drinking fermented milk containing probiotics on immune response against SARs-CoV2 virus after COVID-19 vaccination: a randomized placebo control trial in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240630005

Enrollment

189

Registered

2024-06-30

Start date

2022-02-07

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult individuals SARs-CoV2 probiotics postbiotics immune response vaccine

Interventions

oral intake of 1 bottle/ day of drinking fermented milk containing heat-killed L. pentosus 9D3 for 4 weeks, i.e. 1 week before vaccination and 3 weeks after vaccination ,oral intake of 1 bottle/ day o

Active Comparator Dietary Supplement,Active Comparator Dietary Supplement,Active Comparator Dietary Supplement

Drinking fermented milk containing heat-killed L. pentosus 9D3,Drinking fermented milk containing live L.paracasei ,placebo milk

Eligibility

Sex/Gender

All

Age

20 Years to 59 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
adverse symptoms baseline, before vaccination, 4 weeks, 8 weeks and 12 weeks after vaccination subject diary and interviews	—

Countries

Thailand

Contacts

Public ContactDunyaporn Trachootham

Institute of Nutrition, Mahidol University

dunyaporn.tra@mahidol.edu66846953647

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026