Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2023-03-20
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic
2B Colony Forming Unit/ day
Probiotic effect on influenza vaccine response
Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Ab titre for seronegative subjects.
Placebo
Equivalent placebo
Probiotic effect on influenza vaccine response
Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Ab titre for seronegative subjects.
Interventions
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Probiotic effect on influenza vaccine response
Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Ab titre for seronegative subjects.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
65 Years
ALL
Yes
Sponsors
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NIZO Food Research
OTHER
The Archer-Daniels-Midland Company
INDUSTRY
Responsible Party
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Principal Investigators
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Alwine Kardinaal, PhD
Role: STUDY_CHAIR
NIZO food research B.V
Locations
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Alwine Kardinaal, PhD NIZO food research B.V
Ede, , Netherlands
Countries
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Other Identifiers
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200918
Identifier Type: OTHER
Identifier Source: secondary_id
CTB2022TN106
Identifier Type: -
Identifier Source: org_study_id
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