Clinical trial NCT05656729: Effect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients with an History of Upper Airways Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cold Symptom
Keywords: cold
cold symptoms
probiotics
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cold symptoms evaluation
timeFrame: 18 weeks
Secondary outcomes:
measure: Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
timeFrame: 18 weeks
measure: Change of Short Form Health Survey 36 (SF-36)
timeFrame: 18 weeks
measure: Inflammatory status
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
Study officials:
References: