Probiotics and Influenza Vaccination Response (NCT05690373) | Clinical Trial Compass
CompletedNot Applicable
Probiotics and Influenza Vaccination Response
Netherlands100 participantsStarted 2023-03-20
Plain-language summary
Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study.
Who can participate
Age range16 Years – 65 Years
SexALL
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Inclusion Criteria:
* Men and women
* Age 16 - 65 y and healthy
* Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day)
* No influenza vaccination in 2022
* Non-smokers
* BMI 18.5-28
* Adherence to habitual diet
* no changes during study period
* Signed informed consent
Exclusion Criteria:
* Recent vaccination
* Acute or chronic illness (e.g., diabetes mellitus)
* Gastrointestinal disorders (e.g., inflammatory bowel disease)
* Acute gastroenteritis in the past 2 months
* Immunodeficiency disorder
* Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies)
* Unexplained weight loss or weight gain of \> 3 kg in the 3 months prior to pre-study screening
* Alcohol or drug abuse
* Mental status that is incompatible with the proper conduct of the study
* History of cancer
* Use of immune boosting supplements within 4 weeks before screening To be extended \& specified in protocol phase