Probiotics and Influenza Vaccination Response

The Archer-Daniels-Midland Company100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Vaccine Response

Interventions

Probiotic effect on influenza vaccine responseDIETARY_SUPPLEMENT

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

Sex: ALLMin age: 16 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Alwine Kardinaal, PhD NIZO food research B.V

Ede, Netherlands

Outcomes

Primary Outcomes

Seroconversion rate

Percentage of subjects achieving at least a 4-fold increase or an increase from \>10 to 40 in Antibody titer for seronegative subjects

Time frame: From baseline to week 6

Secondary Outcomes

Change in plasma cytokine levels

Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma)

Time frame: Baseline, week 2 and week 6

Change in IgA antibodies against influenza

Titer of plasma anti-influenza IgA

Time frame: baseline, week 2, week 6

Change in IgG antibodies against influenza

Titer of plasma anti-influenza IgG

Time frame: baseline, week 2, week 6

Change in IgM antibodies against influenza

Titer of plasma anti-influenza IgM

Time frame: baseline, week 2, week 6

Change in Gastrointestinal symptoms

Gastrointestinal manifestations documented through Gastrointestinal Symptom Rating Scale (GSRS, 7-point graded Likert-type scale and includes 15 items combined into 5 symptom clusters - 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms)

Time frame: baseline, week 2, week 6

Change in Incidence of respiratory infections

Assessment of respiratory infection through questionnaire (4-point graded Likert-type scale and includes 11 items, including the 8 items comprising the Jackson common cold questionnaire - 0 = absent, 1 = mild, 2 = moderate, 3 = severe)

Data from ClinicalTrials.gov

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