Cold Symptom Clinical Trial
Official title:
Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli, Sull'Efficacia Clinica di un Prodotto a Base di Probiotici Nel Migliorare i Comuni Sintomi da Raffreddamento e la Risposta Immunitaria in Adulti Sani - ImmunoCold 2021
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
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 44 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria di Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | 18 weeks | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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