Effect of a Multi-strain Probiotic Formulation on Immune Response to Influenza Vaccination
- Conditions
- Influenza Vaccine
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Food Supplement
- Registration Number
- NCT05157425
- Lead Sponsor
- AB Biotics, SA
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Maltodextrin (E1400, qs) in HPMC capsules Experimental Food Supplement 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
- Primary Outcome Measures
Name Time Method IgG antibodies against vaccine influenza antigens 4 weeks (day 1 and day 28) Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28
- Secondary Outcome Measures
Name Time Method Aspartate aminotransferase (GOT) 4 weeks (day 1, day 28) Aspartate aminotransferase (AST) concentration in blood
IgG antibodies against vaccine influenza antigens 8 weeks (day 1 and day 56) Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56
Incidence of fever 16 weeks (day 1, day 56) Cumulative number of days with fever (\> 37.5ºC)
IgM antibodies against vaccine influenza antigens 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
Incidence of any other respiratory infections (including COVID-19) 16 weeks (day 1, day 56) Cumulative incidence of any other respiratory infections
Duration of vaccine-related symptoms: injection-site pain, swelling, redness 1 week (day 1, day 7) Duration (in days) of symptoms after receiving the flu vaccine.
Adverse events 8 weeks (day 56) Frequency of adverse events reported in medical visits or patient diary
Albumin 4 weeks (day 1, day 28) Albumin concentration in blood
Alanine aminotransferase (AST) 4 weeks (day 1, day 28) Aspartate aminotransferase (AST) concentration in blood
Basic hemogram 4 weeks (day 1, day 28) Blood cell count
Seroconversion 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
Use of analgesics and antibiotics 16 weeks (day 1, day 56) Cumulative number of days using analgesics and antibiotics
Severity of vaccine-related symptoms: injection-site pain, swelling, redness 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
Gamma-glutamil transpeptidase (GGT) 4 weeks (day 1, day 28) Gamma-glutamil transpeptidase (GGT) concentration in blood
Incidence of influenza like infections (ILI) 16 weeks (day 1, day 56) Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria
Gastrointestinal symptoms 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.
Alkaline phosphatase (ALP) 4 weeks (day 1, day 28) Alkaline phosphatase (ALP) concentration in blood
Trial Locations
- Locations (5)
IDIAP Jordi Gol-Centro de Atención Primaria La Mina
🇪🇸Sant Adrià De Besòs, Barcelona, Spain
Hospital Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
FIBAO- Fundación para la Investigación Biosanitaria de Andalucia Oriental
🇪🇸Granada, Spain