Effect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients With an History of Upper Airways Infection

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Cold Symptom

Intervention / Treatment
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* Dietary Supplement: DefensePlus
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo 8-week daily administration | Dietary Supplement: Placebo<br>* Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide<br>|
| Active Comparator: Multistrain probiotic<br>Dietary Supplement: Multistrain Probiotic 12-week daily administration | Dietary Supplement: DefensePlus<br>* Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold, cold symptoms, probiotics