Probiotics and Influenza Vaccination Response

Vaccine Response Clinical Trial

— VERB  

Official title:

Effects of Probiotics in Immune Response to Influenza Vaccination in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05690373
• Other study ID #: CTB2022TN106
• Secondary ID: 200918
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: The Archer-Daniels-Midland Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human
• Vaccine Response

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Alwine Kardinaal, PhD NIZO food research B.V	Ede

Sponsors (2)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company	NIZO Food Research

Country where clinical trial is conducted

Netherlands, 

Outcome

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