Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination (FLUVAC21)

July 25, 2022 updated by: AB Biotics, SA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18002
        • FIBAO- Fundación para la Investigación Biosanitaria de Andalucia Oriental
    • Barcelona
      • Granollers, Barcelona, Spain, 08401
        • Hospital General de Granollers
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli
      • Sant Adrià De Besòs, Barcelona, Spain, 08930
        • IDIAP Jordi Gol-Centro de Atención Primaria La Mina
      • Terrassa, Barcelona, Spain, 08221
        • Mutua de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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

Exclusion criteria during the study:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Probiotic multistrain formulation containing Lactiplantibacillus plantarum CECT30292, CECT7484, CECT7485 and P. acidilactici CECT7483 for 28 days, starting the same day of influenza vaccination
Other Names:
  • Probiotic
Placebo Comparator: Placebo
Maltodextrin (E1400, qs) in HPMC capsules
Dietary supplement: Placebo
One maltodextrin-containing capsule/day for 28 days, starting the same day of influenza vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgG antibodies against vaccine influenza antigens
Time Frame: 4 weeks (day 1 and day 28)
Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28
4 weeks (day 1 and day 28)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgG antibodies against vaccine influenza antigens
Time Frame: 8 weeks (day 1 and day 56)
Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56
8 weeks (day 1 and day 56)
IgM antibodies against vaccine influenza antigens
Time Frame: 8 weeks (day 1 and day 56)
Titer of specific total IgM antibodies against vaccine influenza A and B antigens at day 28 and 56
8 weeks (day 1 and day 56)
Seroconversion
Time Frame: 8 weeks (day 1,day 28 and 56)
Percentage of patients with seroconversion (defined as 4 fold change in influenza IgG antibodies concentration compared to baseline) at day 28 and 56
8 weeks (day 1,day 28 and 56)
Incidence of influenza like infections (ILI)
Time Frame: 16 weeks (day 1, day 56)
Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria
16 weeks (day 1, day 56)
Incidence of any other respiratory infections (including COVID-19)
Time Frame: 16 weeks (day 1, day 56)
Cumulative incidence of any other respiratory infections
16 weeks (day 1, day 56)
Incidence of fever
Time Frame: 16 weeks (day 1, day 56)
Cumulative number of days with fever (> 37.5ºC)
16 weeks (day 1, day 56)
Use of analgesics and antibiotics
Time Frame: 16 weeks (day 1, day 56)
Cumulative number of days using analgesics and antibiotics
16 weeks (day 1, day 56)
Duration of vaccine-related symptoms: injection-site pain, swelling, redness
Time Frame: 1 week (day 1, day 7)
Duration (in days) of symptoms after receiving the flu vaccine.
1 week (day 1, day 7)
Severity of vaccine-related symptoms: injection-site pain, swelling, redness
Time Frame: 1 week (day 1, day 7)
Severity of symptoms after receiving the flu vaccine. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe
1 week (day 1, day 7)
Gastrointestinal symptoms
Time Frame: 4 weeks (day 1, day 28)
Gastrointestinal manifestations documented through questionnaire in participants diary. Measured on a 4-point scale: 0 = none , 1 = mild, 2 = moderate, and 3 = severe.
4 weeks (day 1, day 28)
Adverse events
Time Frame: 8 weeks (day 56)
Frequency of adverse events reported in medical visits or patient diary
8 weeks (day 56)
Albumin
Time Frame: 4 weeks (day 1, day 28)
Albumin concentration in blood
4 weeks (day 1, day 28)
Alkaline phosphatase (ALP)
Time Frame: 4 weeks (day 1, day 28)
Alkaline phosphatase (ALP) concentration in blood
4 weeks (day 1, day 28)
Gamma-glutamil transpeptidase (GGT)
Time Frame: 4 weeks (day 1, day 28)
Gamma-glutamil transpeptidase (GGT) concentration in blood
4 weeks (day 1, day 28)
Aspartate aminotransferase (GOT)
Time Frame: 4 weeks (day 1, day 28)
Aspartate aminotransferase (AST) concentration in blood
4 weeks (day 1, day 28)
Alanine aminotransferase (AST)
Time Frame: 4 weeks (day 1, day 28)
Aspartate aminotransferase (AST) concentration in blood
4 weeks (day 1, day 28)
Basic hemogram
Time Frame: 4 weeks (day 1, day 28)
Blood cell count
4 weeks (day 1, day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Biotics, SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-FLUVAC21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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