NCT05690373CompletedNot Applicable
Effects of Probiotics in Immune Response to Influenza Vaccination in Adults
The Archer-Daniels-Midland Company1 site in 1 country100 target enrollmentStarted: March 20, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Seroconversion rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Seroconversion rate
Time Frame: From baseline to week 6
Percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Antibody titer for seronegative subjects
Secondary Outcomes
- Change in plasma cytokine levels(Baseline, week 2 and week 6)
- Change in IgA antibodies against influenza(baseline, week 2, week 6)
- Change in IgG antibodies against influenza(baseline, week 2, week 6)
- Change in IgM antibodies against influenza(baseline, week 2, week 6)
- Change in Gastrointestinal symptoms(baseline, week 2, week 6)
- Change in Incidence of respiratory infections(baseline, week 2, week 6)
Investigators
Study Sites (1)
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