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 range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at whether taking probiotics could improve how well people respond to the flu vaccine — is there anything in the published results about seroconversion rates that might be relevant to how I personally respond to flu shots?
2Since this study has already been completed, has the data been published anywhere, and would my doctor be able to review the findings to see if probiotics might be worth adding before my next influenza vaccination?
3The trial didn't have a traditional phase label, which suggests it may have been more of an exploratory or observational study — does that affect how much weight my doctor would put on its conclusions compared to a Phase 2 or Phase 3 trial?
4Are there any specific types or strains of probiotics that were used in this trial that my doctor thinks are safe for me to try, or are there reasons my health history might make that a concern?
5If the results showed that probiotics helped improve vaccine response, would my doctor consider that a strong enough signal to recommend I try it before my next flu shot, or would they want to wait for more evidence first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.