Probiotics and Influenza Vaccination Response (VERB)

Effects of Probiotics in Immune Response to Influenza Vaccination in Adults

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 Overview

• Status: Completed
• Conditions: Vaccine Response
• Intervention / Treatment: Dietary supplement: Probiotic effect on influenza vaccine response

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Ede, Netherlands
    • Alwine Kardinaal, PhD NIZO food research B.V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; 2B Colony Forming Unit/ day	Dietary supplement: 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 Comparator: Placebo; Equivalent placebo	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma cytokine levels	Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma)	Baseline, week 2 and week 6
Change in IgA antibodies against influenza	Titer of plasma anti-influenza IgA	baseline, week 2, week 6
Change in IgG antibodies against influenza	Titer of plasma anti-influenza IgG	baseline, week 2, week 6
Change in IgM antibodies against influenza	Titer of plasma anti-influenza IgM	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)	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)	baseline, week 2, week 6

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: NIZO Food Research
• Investigators: Study Chair: Alwine Kardinaal, PhD, NIZO food research B.V

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: antibody; seroconversion; vaccine response
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: CTB2022TN106; 200918 (Other Identifier: CRO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No