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

Not Applicable

Completed

• Conditions: Cold Symptom
• Interventions: Dietary Supplement: DefensePlus; Dietary Supplement: Placebo

• Registration Number: NCT05656729
• Lead Sponsor: Università degli Studi di Ferrara

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.

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-19
• Study Start: 2022-12-22
• Status Verified: 2024-04
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multistrain probiotic	DefensePlus	Dietary Supplement: Multistrain Probiotic 12-week daily administration
Placebo	Placebo	Placebo 8-week daily administration

Primary Outcome Measures

Name	Time	Method
Cold symptoms evaluation	18 weeks	Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms

Secondary Outcome Measures

Name	Time	Method
Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)	18 weeks	Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms
Change of Short Form Health Survey 36 (SF-36)	18 weeks	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
Inflammatory status	18 weeks	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

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria di Ferrara; 🇮🇹 Ferrara, Italy