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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656729
• Other study ID #: ImmunoCold 2021
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Università degli Studi di Ferrara
• Contact: Giacomo Caio, MD, PhD
• Phone: +390532236823
• Email: caigmp[@]unife.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cold Symptom
• Nasopharyngitis

Intervention

Dietary Supplement:
• DefensePlus
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
• Placebo
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria di Ferrara	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

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