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Influenza VaccineFLUVAC21NCT05157425

Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination

A study testing Food Supplement in people with Influenza Vaccine, run by AB Biotics, SA at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species can boost the immune response to influenza vaccination evaluated at 4 weeks in a population between 50 and 80 years of age. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Influenza Vaccine
What is being tested?
Food Supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
5 sitesSpain
Study dates
26 Oct 2021to 31 May 2022
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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects 50 - 80 years old receiving seasonal Influenza vaccine in season 2021-2022
  • Body mass index (BMI) 18.5-34.9 kg/m2
  • Willing to provide informed consent
  • Able to follow study procedures, according to the criteria of study investigator

Who cannot join

  • Hypersensitivity to any of the components of influenza vaccine
  • Previous influenza infection in the same season (from 01/09/2021)
  • Having received influenza vaccination in the previous season less than 9 months before study entry (from 01/01/2021)
  • Having received another vaccine -different from COVID19 vaccine- up to 1 month before study inclusion or planning to receive it 1 month after study inclusion
  • Active infection at the moment of study entry as diagnosed by study physician
  • History of severe allergic reactions (food and non-food), including severe asthma.
Show all 15Show fewer
  • Receiving immunosuppressant therapy, displaying neutropenia, lymphopenia, AIDS, immunoglobulin deficiency, active oncological disease.
  • Daily ingestion of any food complement or food added with probiotics (including Actimel o similar products) 2 weeks before inclusion in the study
  • Acute pancreatitis, short bowel syndrome or active inflammatory bowel disease
  • Diagnosed from other pathologies that according to study physician may compromise the immunological function of the individual (such as immunodeficiencies, lupus, multiple sclerosis, among others)
  • Having received antibiotic treatment in the previous month
  • Withdrawal from the study as per study investigator criteria, in case that study procedures are not followed by the participant
  • In case of adverse event that prevents them from following study procedures or complying with the treatments under study.
  • Failure to comply with study procedures: Complete less than 70% of the days in the patient's diary and/or take less than 80% of the days of the study products.
  • Receive any of the unauthorized treatments indicated in the selection criteria, with the exception of antibiotics that will be allowed under medical prescription.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • FIBAO- Fundación para la Investigación Biosanitaria de Andalucia Oriental

    Granada, 18002

  • Hospital General de Granollers

    Granollers, Barcelona, 08401

  • Hospital Parc Tauli

    Sabadell, Barcelona, 08208

  • IDIAP Jordi Gol-Centro de Atención Primaria La Mina

    Sant Adrià de Besòs, Barcelona, 08930

  • Mutua de Terrassa

    Terrassa, Barcelona, 08221

Other trials in Spain

About this study

Official title: Efficacy and Safety of a Multistrain Probiotic Formula to Boost the Immune Response to Influenza Virus Vaccination

Randomized clinical trial to determine whether a probiotic formulation containing 4 probiotic strains which belong to Lactiplantibacillus plantarum and Pediococcus acidilactici species can boost the immune response to influenza vaccination evaluated at 4 weeks in a population between 50 and 80 years of age. Secondary outcomes comprise evaluation of immune response at 8 weeks after vaccination, percentage of patients with seroconversion, incidence and duration of influenza-like infections and respiratory infections throughout a 4-month period and safety.

Read the detailed description

Double blind, randomized, placebo-controlled clinical trial to determine whether supplementation with a probiotic formulation containing 4 probiotic strains (L. plantarum CECT 30292, CECT7484, CECT7485 and P. acidilactici CECT7483) can improve immune response to seasonal influenza vaccination. Subjects with age comprised between 50 and 80 years who meet inclusion and exclusion criteria will be randomized 1:1 to one of the following study groups: one will receive probiotic formulation for 28 days (1 capsule/day) and the other will receive placebo, starting the same day of the influenza vaccination. Main study outcome will be immune response at 4 weeks after vaccination, which will be determined by analysis of specific IgG antibodies in serum against influenza A and B. Secondary outcomes comprise serum titers of specific IgG at 8 weeks after vaccination, percentage of patients with seroconversion at 4 and 8 weeks, evaluation of influenza-like infections or respiratory infections throughout a 4-month period and adverse events.

Being tested
Food Supplement, Placebo
Keywords
influenza vaccination, probiotic
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food SupplementDietary supplement

    Also called Probiotic

    Probiotic multistrain formulation containing Lactiplantibacillus plantarum CECT30292, CECT7484, CECT7485 and P. acidilactici CECT7483 for 28 days, starting the same day of influenza vaccination

  • PlaceboDietary supplement

    One maltodextrin-containing capsule/day for 28 days, starting the same day of influenza vaccination

Study groups in NCT05157425
Study groupRoleWhat they receive
ExperimentalExperimentalProbiotic multi-strain formulation comprising L. plantarum CECT30292, CECT7484, CECT7585 and P. acidilactici and maltodextrin (E1400, qs) as excipient in hydroxymethylpropyl-cellulose (HPMC) capsules. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority
Receives: Dietary Supplement: Food Supplement
PlaceboPlacebo comparatorMaltodextrin (E1400, qs) in HPMC capsules
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IgG antibodies against vaccine influenza antigens

    Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28

    Measured: 4 weeks (day 1 and day 28)

Secondary outcomes (17)

  1. IgG antibodies against vaccine influenza antigens

    Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56

    Measured: 8 weeks (day 1 and day 56)

  2. IgM antibodies against vaccine influenza antigens

    Titer of specific total IgM antibodies against vaccine influenza A and B antigens at day 28 and 56

    Measured: 8 weeks (day 1 and day 56)

  3. Seroconversion

    Percentage of patients with seroconversion (defined as 4 fold change in influenza IgG antibodies concentration compared to baseline) at day 28 and 56

    Measured: 8 weeks (day 1,day 28 and 56)

  4. Incidence of influenza like infections (ILI)

    Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria

    Measured: 16 weeks (day 1, day 56)

  5. Incidence of any other respiratory infections (including COVID-19)

    Cumulative incidence of any other respiratory infections

    Measured: 16 weeks (day 1, day 56)

  6. Incidence of fever

    Cumulative number of days with fever (> 37.5ºC)

    Measured: 16 weeks (day 1, day 56)

  7. Use of analgesics and antibiotics

    Cumulative number of days using analgesics and antibiotics

    Measured: 16 weeks (day 1, day 56)

  8. Duration of vaccine-related symptoms: injection-site pain, swelling, redness

    Duration (in days) of symptoms after receiving the flu vaccine.

    Measured: 1 week (day 1, day 7)

  9. Severity of vaccine-related symptoms: injection-site pain, swelling, redness

    Severity of symptoms after receiving the flu vaccine. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe

    Measured: 1 week (day 1, day 7)

  10. Gastrointestinal symptoms

    Gastrointestinal manifestations documented through questionnaire in participants diary. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.

    Measured: 4 weeks (day 1, day 28)

  11. Adverse events

    Frequency of adverse events reported in medical visits or patient diary

    Measured: 8 weeks (day 56)

  12. Albumin

    Albumin concentration in blood

    Measured: 4 weeks (day 1, day 28)

  13. Alkaline phosphatase (ALP)

    Alkaline phosphatase (ALP) concentration in blood

    Measured: 4 weeks (day 1, day 28)

  14. Gamma-glutamil transpeptidase (GGT)

    Gamma-glutamil transpeptidase (GGT) concentration in blood

    Measured: 4 weeks (day 1, day 28)

  15. Aspartate aminotransferase (GOT)

    Aspartate aminotransferase (AST) concentration in blood

    Measured: 4 weeks (day 1, day 28)

  16. Alanine aminotransferase (AST)

    Aspartate aminotransferase (AST) concentration in blood

    Measured: 4 weeks (day 1, day 28)

  17. Basic hemogram

    Blood cell count

    Measured: 4 weeks (day 1, day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start26 Oct 2021
  3. Primary completion28 Feb 2022
  4. Study completion31 May 2022

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, randomized controlled trial in 140 subjects 50-80 years old receiving influenza vaccination, who will be allocated to receive either an experimental product containing multi-strain probiotic formula or placebo for 28 days
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157425
Sponsor's protocol ID
AB-FLUVAC21
Acronym
FLUVAC21
Status last verified
Jul 2022
First submitted
19 Nov 2021
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lambert ND, Ovsyannikova IG, Pankratz VS, Jacobson RM, Poland GA. Understanding the immune response to seasonal influenza vaccination in older adults: a systems biology approach. Expert Rev Vaccines. 2012 Aug;11(8):985-94. doi: 10.1586/erv.12.61.

    PubMed 23002979

  • Ng TWY, Cowling BJ, Gao HZ, Thompson MG. Comparative Immunogenicity of Enhanced Seasonal Influenza Vaccines in Older Adults: A Systematic Review and Meta-analysis. J Infect Dis. 2019 Apr 19;219(10):1525-1535. doi: 10.1093/infdis/jiy720.

    PubMed 30551178

  • Harper A, Vijayakumar V, Ouwehand AC, Ter Haar J, Obis D, Espadaler J, Binda S, Desiraju S, Day R. Viral Infections, the Microbiome, and Probiotics. Front Cell Infect Microbiol. 2021 Feb 12;10:596166. doi: 10.3389/fcimb.2020.596166. eCollection 2020.

    PubMed 33643929

  • Trombetta CM, Remarque EJ, Mortier D, Montomoli E. Comparison of hemagglutination inhibition, single radial hemolysis, virus neutralization assays, and ELISA to detect antibody levels against seasonal influenza viruses. Influenza Other Respir Viruses. 2018 Nov;12(6):675-686. doi: 10.1111/irv.12591. Epub 2018 Aug 11.

    PubMed 30019448

  • Lynn DJ, Benson SC, Lynn MA, Pulendran B. Modulation of immune responses to vaccination by the microbiota: implications and potential mechanisms. Nat Rev Immunol. 2022 Jan;22(1):33-46. doi: 10.1038/s41577-021-00554-7. Epub 2021 May 17.

    PubMed 34002068

  • Zimmermann P, Curtis N. The influence of probiotics on vaccine responses - A systematic review. Vaccine. 2018 Jan 4;36(2):207-213. doi: 10.1016/j.vaccine.2017.08.069. Epub 2017 Sep 18.

    PubMed 28923425

  • Yeh TL, Shih PC, Liu SJ, Lin CH, Liu JM, Lei WT, Lin CY. The influence of prebiotic or probiotic supplementation on antibody titers after influenza vaccination: a systematic review and meta-analysis of randomized controlled trials. Drug Des Devel Ther. 2018 Jan 25;12:217-230. doi: 10.2147/DDDT.S155110. eCollection 2018.

    PubMed 29416317

  • Darbandi A, Asadi A, Ghanavati R, Afifirad R, Darb Emamie A, Kakanj M, Talebi M. The effect of probiotics on respiratory tract infection with special emphasis on COVID-19: Systemic review 2010-20. Int J Infect Dis. 2021 Apr;105:91-104. doi: 10.1016/j.ijid.2021.02.011. Epub 2021 Feb 9.

    PubMed 33578007

Questions about this trial

What is this clinical trial studying?

A study testing Food Supplement in people with Influenza Vaccine, run by AB Biotics, SA at 5 sites in Spain.

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 4 inclusion and 15 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. 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?

IgG antibodies against vaccine influenza antigens (time frame: 4 weeks (day 1 and day 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05157425, which also lists 8 linked publications.

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 26 Jul 2022.

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