The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response
Adult subjects (age 18-44) with a history of upper airways infection, will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 12 weeks. After that, a 6 weeks follow-up. The answers at: Common Cold Questionnarie (CCQ), Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21) and quality of life score (SF-36) will be compared in the two groups. In addition, serological markers (blood count, lymphocyte subpopulation (B, T, T4, T8, NK), IFN-γ and IL-10 levels) will be evaluated over a 18 week period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Ferrara, Italy
Cold symptoms evaluation
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
Time frame: 18 weeks
Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms
Time frame: 18 weeks
Change of Short Form Health Survey 36 (SF-36)
Higher score on Short Form Health Survey 36 (SF-36) questionnaire will be considered as an improvement of life quality. Highest score: 147, Lowest 0. Higher scores indicate better perception of one's health
Time frame: 18 weeks
Inflammatory status
A reduction of inflammatory markers (INF-y, IL-10, and lymphocite B, T, T4, T8, NK) will be considered as an improvement of inflammatory status
Time frame: 18 weeks
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