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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 8-week daily administration |
|
| Multistrain probiotic | Active Comparator | Dietary Supplement: Multistrain Probiotic 12-week daily administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DefensePlus | Dietary Supplement | Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 weeks |
| Change of Short Form Health Survey 36 (SF-36) |
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Inclusion Criteria:
people who:
Exclusion Criteria:
subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria di Ferrara | Ferrara | Ferrara | 44124 | Italy |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Dietary Supplement | Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide |
|
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 |
| 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 | 18 weeks |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |