Probiotics and Influenza Vaccination Response (VERB)

The Archer-Daniels-Midland Company

Status: Completed

Conditions: Vaccine Response

Treatments: Dietary Supplement: Probiotic effect on influenza vaccine response

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05690373

200918 (Other Identifier)

CTB2022TN106

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

2B Colony Forming Unit/ day

Treatment:

Dietary Supplement: Probiotic effect on influenza vaccine response

Placebo

Placebo Comparator group

Description:

Equivalent placebo

Treatment:

Dietary Supplement: Probiotic effect on influenza vaccine response