VERB: Probiotics and Influenza Vaccination Response

Sponsor

The Archer-Daniels-Midland Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05690373

Collaborator

NIZO Food Research (Other)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Response	Dietary Supplement: Probiotic effect on influenza vaccine response	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Probiotics in Immune Response to Influenza Vaccination in Adults

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Seroconversion rate [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 Outcome Measures

Change in plasma cytokine levels [Baseline, week 2 and week 6]
Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma)
Change in IgA antibodies against influenza [baseline, week 2, week 6]
Titer of plasma anti-influenza IgA
Change in IgG antibodies against influenza [baseline, week 2, week 6]
Titer of plasma anti-influenza IgG
Change in IgM antibodies against influenza [baseline, week 2, week 6]
Titer of plasma anti-influenza IgM
Change in Gastrointestinal symptoms [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)
Change in Incidence of respiratory infections [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Archer-Daniels-Midland Company
NIZO Food Research

Investigators

Study Chair: Alwine Kardinaal, PhD, NIZO food research B.V

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Archer-Daniels-Midland Company

ClinicalTrials.gov Identifier:

NCT05690373

Other Study ID Numbers:

CTB2022TN106
200918

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Archer-Daniels-Midland Company

vaccine response

seroconversion

antibody

Study Results

No Results Posted as of Jan 25, 2023