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OpenTrials
Completed

NCT Number: NCT05690373

Probiotics and Influenza Vaccination Response

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.

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Key information

Conditions

Vaccine Response Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Seropositivity Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alwine Kardinaal, PhD NIZO food research B.V

Ede, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic effect on influenza vaccine response

Dietary 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.

Primary outcomes

  1. Seroconversion rate

    Time frame: 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 outcomes

  1. Change in plasma cytokine levels

    Time frame: Baseline, week 2 and week 6

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

  2. Change in IgA antibodies against influenza

    Time frame: baseline, week 2, week 6

    Titer of plasma anti-influenza IgA

  3. Change in IgG antibodies against influenza

    Time frame: baseline, week 2, week 6

    Titer of plasma anti-influenza IgG

  4. Change in IgM antibodies against influenza

    Time frame: baseline, week 2, week 6

    Titer of plasma anti-influenza IgM

  5. Change in Gastrointestinal symptoms

    Time frame: 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)

  6. Change in Incidence of respiratory infections

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

The Archer-Daniels-Midland Company

Industry

Collaborators

  • NIZO Food Research

Registry information

Official study title

Effects of Probiotics in Immune Response to Influenza Vaccination in Adults

Acronym: VERB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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