Cold Symptom
Conditions
Keywords
cold, cold symptoms, probiotics
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTDefensePlus
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
DIETARY_SUPPLEMENTPlacebo
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Sponsors
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
people who: * are willing and capable of joining the study * are willing of not varying their routine (lifestyle, physical activity..) during the study * are willing of not varying their diet during the study * are willing of using only the testing product during the study * are willing of not using products that may interfere with the testing product * have not recently joined similar studies * have signed informed consent
Exclusion criteria
subjects: * not filling the inclusion criteria * with suspected or confirmed sensibility to one or more product component * with chronic diseases (cardiovascular congenital diseases, hepatic diseases, renal disease, immunodeficiency) * undergoing antibiotic/pharmacological treatment * with other concomitant disease (infective, respiratory, gastrointestinal, immune) * who underwent an immunomodulating treatment in the past 4 weeks * who underwent an immunosuppressant therapy in the past 3 months * with severe disease ongoing * who abuse of alcohol and/or drugs * who are considered not eligible by the investigator * not able to communicate due to language barriers, mental issues or cerebral functioning impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cold symptoms evaluation | 18 weeks | Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21) | 18 weeks | Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms |
| Change of Short Form Health Survey 36 (SF-36) | 18 weeks | 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 |
| Inflammatory status | 18 weeks | 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 |
Countries
Italy
Outcome results
None listed