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

NCT05157425 | Completed

• 1 other identifier: AB-FLUVAC21
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Influenza Vaccine

Keywords

influenza vaccination, probiotic

Outcome Measures

Primary Outcomes (1)

• IgG antibodies against vaccine influenza antigens

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

  4 weeks (day 1 and day 28)

Secondary Outcomes (17)

• IgG antibodies against vaccine influenza antigens

  8 weeks (day 1 and day 56)

• IgM antibodies against vaccine influenza antigens

  8 weeks (day 1 and day 56)

• Seroconversion

  8 weeks (day 1,day 28 and 56)

• Incidence of influenza like infections (ILI)

  16 weeks (day 1, day 56)

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

  16 weeks (day 1, day 56)

Study Arms (2)

Experimental

EXPERIMENTAL

Probiotic 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

Dietary Supplement: Food Supplement

Placebo

PLACEBO COMPARATOR

Maltodextrin (E1400, qs) in HPMC capsules

Dietary Supplement: Placebo

Interventions

Food Supplement DIETARY_SUPPLEMENT

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

Also known as: Probiotic

Experimental

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.
• Receiving immunosuppressant therapy, displaying neutropenia, lymphopenia, AIDS, immunoglobulin deficiency, active oncological disease.
• 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.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (5)

Hospital General de Granollers

Granollers, Barcelona, 08401, Spain

Location

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

IDIAP Jordi Gol-Centro de Atención Primaria La Mina

Sant Adrià de Besòs, Barcelona, 08930, Spain

Location

Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

FIBAO- Fundación para la Investigación Biosanitaria de Andalucia Oriental

Granada, 18002, Spain

Location

Related Publications (8)

• 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.

  PMID: 23002979 BACKGROUND

• 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.

  PMID: 30551178 BACKGROUND

• 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.

  PMID: 33643929 BACKGROUND

• 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.

  PMID: 30019448 BACKGROUND

• 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.

  PMID: 34002068 BACKGROUND

• 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.

  PMID: 28923425 RESULT

• 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.

  PMID: 29416317 RESULT

• 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.

  PMID: 33578007 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Dietary Supplements; Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both placebo and active product will be provided in identical packaging.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 15, 2021
• Study Start: October 26, 2021
• Primary Completion: February 28, 2022
• Study Completion: May 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)