Vaccine ResponseVERBNCT05690373
Probiotics and Influenza Vaccination Response
A study testing Probiotic effect on influenza vaccine response in people with Vaccine Response, run by The Archer-Daniels-Midland Company at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response
- What is being tested?
- Probiotic effect on influenza vaccine response
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- Adherence to habitual diet
- no changes during study period
- Signed informed consent
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotics in Immune Response to Influenza Vaccination in Adults
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
- Being tested
- Probiotic effect on influenza vaccine response
- Keywords
- vaccine response, seroconversion, antibody
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic effect on influenza vaccine responseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 2B Colony Forming Unit/ day Receives: Dietary Supplement: Probiotic effect on influenza vaccine response |
| Placebo | Placebo comparator | Equivalent placebo Receives: Dietary Supplement: Probiotic effect on influenza vaccine response |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to week 6
Secondary outcomes (6)
Change in plasma cytokine levels
Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma)
Measured: Baseline, week 2 and week 6
Change in IgA antibodies against influenza
Titer of plasma anti-influenza IgA
Measured: baseline, week 2, week 6
Change in IgG antibodies against influenza
Titer of plasma anti-influenza IgG
Measured: baseline, week 2, week 6
Change in IgM antibodies against influenza
Titer of plasma anti-influenza IgM
Measured: baseline, week 2, week 6
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)
Measured: baseline, week 2, week 6
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)
Measured: baseline, week 2, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start20 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research
- Responsible party
- Sponsor
- Investigators
- Alwine Kardinaal, PhD, Study chair, NIZO food research B.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690373
- Sponsor's protocol ID
- CTB2022TN106
- Other IDs
- 200918
- Acronym
- VERB
- Status last verified
- Aug 2023
- First submitted
- 10 Jan 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics in Immune Response to Influenza Vaccination in Adults
- ClinicalTrials.gov ID
- NCT05690373
- Acronym / sponsor ID
- VERB / CTB2022TN106
- Conditions
- Vaccine Response
- Keywords
- vaccine response, seroconversion, antibody
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- NIZO Food Research
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic effect on influenza vaccine response2B Colony Forming Unit/ day |
| Placebo | Placebo comparator | Dietary Supplement: Probiotic effect on influenza vaccine responseEquivalent placebo |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic effect on influenza vaccine responseSeroconversion 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. | Dietary supplement | Placebo, Probiotic |
Primary outcome
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
6 secondary outcomes
Change in plasma cytokine levels
Time frame: Baseline, week 2 and week 6
Change in IgA antibodies against influenza
Time frame: baseline, week 2, week 6
Change in IgG antibodies against influenza
Time frame: baseline, week 2, week 6
Change in IgM antibodies against influenza
Time frame: baseline, week 2, week 6
Change in Gastrointestinal symptoms
Time frame: baseline, week 2, week 6
Change in Incidence of respiratory infections
Time frame: baseline, week 2, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alwine Kardinaal, PhD study chair
NIZO food research B.V
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic effect on influenza vaccine response in people with Vaccine Response, run by The Archer-Daniels-Midland Company at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: From baseline to week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.