Probiotics and Influenza Vaccination Response

Not Applicable

Completed

• Conditions: Vaccine Response
• Interventions: Dietary Supplement: Probiotic effect on influenza vaccine response

• Registration Number: NCT05690373
• Lead Sponsor: The Archer-Daniels-Midland Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-03-20
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic effect on influenza vaccine response	2B Colony Forming Unit/ day
Placebo	Probiotic effect on influenza vaccine response	Equivalent placebo

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	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 Outcome Measures

Name	Time	Method
Change in plasma cytokine levels	Baseline, week 2 and week 6	Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma)
Change in IgA antibodies against influenza	baseline, week 2, week 6	Titer of plasma anti-influenza IgA
Change in IgG antibodies against influenza	baseline, week 2, week 6	Titer of plasma anti-influenza IgG
Change in IgM antibodies against influenza	baseline, week 2, week 6	Titer of plasma anti-influenza IgM
Change in Gastrointestinal symptoms	baseline, week 2, week 6	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)
Change in Incidence of respiratory infections	baseline, week 2, week 6	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)

Trial Locations

Locations (1)

Alwine Kardinaal, PhD NIZO food research B.V; 🇳🇱 Ede, Netherlands