An interventional study of Food Supplement and Placebo in Influenza Vaccine, sponsored by AB Biotics, SA. Completed at 5 sites in Spain. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.
Sponsored by AB Biotics, SA · Not applicable, Interventional, and Other
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.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 140 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →AB Biotics, SA is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria during the study:
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
Maltodextrin (E1400, qs) in HPMC capsules
Dietary Supplement: Placebo
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
One maltodextrin-containing capsule/day for 28 days, starting the same day of influenza vaccination
IgG antibodies against vaccine influenza antigens
Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 28
Time frame: 4 weeks (day 1 and day 28)
IgG antibodies against vaccine influenza antigens
Titer of specific total IgG antibodies against vaccine influenza A and B antigens at day 56
Time frame: 8 weeks (day 1 and day 56)
IgM antibodies against vaccine influenza antigens
Titer of specific total IgM antibodies against vaccine influenza A and B antigens at day 28 and 56
Time frame: 8 weeks (day 1 and day 56)
Seroconversion
Percentage of patients with seroconversion (defined as 4 fold change in influenza IgG antibodies concentration compared to baseline) at day 28 and 56
Time frame: 8 weeks (day 1,day 28 and 56)
Incidence of influenza like infections (ILI)
Cumulative incidence of influenza like infection (ILI), according to the European Diseases Prevention and Control Center (ECDC) criteria
Time frame: 16 weeks (day 1, day 56)
Incidence of any other respiratory infections (including COVID-19)
Cumulative incidence of any other respiratory infections
Time frame: 16 weeks (day 1, day 56)
Incidence of fever
Cumulative number of days with fever (\> 37.5ºC)
Time frame: 16 weeks (day 1, day 56)
Use of analgesics and antibiotics
Cumulative number of days using analgesics and antibiotics
Time frame: 16 weeks (day 1, day 56)
Duration of vaccine-related symptoms: injection-site pain, swelling, redness
Duration (in days) of symptoms after receiving the flu vaccine.
Time frame: 1 week (day 1, day 7)
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
Time frame: 1 week (day 1, day 7)
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.
Time frame: 4 weeks (day 1, day 28)
Adverse events
Frequency of adverse events reported in medical visits or patient diary
Time frame: 8 weeks (day 56)
Albumin
Albumin concentration in blood
Time frame: 4 weeks (day 1, day 28)
Alkaline phosphatase (ALP)
Alkaline phosphatase (ALP) concentration in blood
Time frame: 4 weeks (day 1, day 28)
Gamma-glutamil transpeptidase (GGT)
Gamma-glutamil transpeptidase (GGT) concentration in blood
Time frame: 4 weeks (day 1, day 28)
Aspartate aminotransferase (GOT)
Aspartate aminotransferase (AST) concentration in blood
Time frame: 4 weeks (day 1, day 28)
Alanine aminotransferase (AST)
Aspartate aminotransferase (AST) concentration in blood
Time frame: 4 weeks (day 1, day 28)
Basic hemogram
Blood cell count
Time frame: 4 weeks (day 1, day 28)
Plan to share: No
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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AB Biotics, SA