Probiotics and Influenza Vaccination Response

NCT05690373 | Completed

• 2 other identifiers: CTB2022TN106200918
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Response

Keywords

vaccine response; seroconversion; antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in plasma cytokine levels

  Baseline, week 2 and week 6

• Change in IgA antibodies against influenza

  baseline, week 2, week 6

• Change in IgG antibodies against influenza

  baseline, week 2, week 6

• Change in IgM antibodies against influenza

  baseline, week 2, week 6

• Change in Gastrointestinal symptoms

  baseline, week 2, week 6

Study Arms (2)

Probiotic

EXPERIMENTAL

2B Colony Forming Unit/ day

Dietary Supplement: Probiotic effect on influenza vaccine response

Placebo

PLACEBO COMPARATOR

Equivalent placebo

Dietary Supplement: Probiotic effect on influenza vaccine response

Interventions

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.

Placebo; Probiotic

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• NIZO Food Research: collaborator

Study Sites (1)

Alwine Kardinaal, PhD NIZO food research B.V

Ede, Netherlands

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Alwine Kardinaal, PhD

  NIZO food research B.V

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: March 20, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)