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

Overview

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

Full Title of Study: “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

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: May 2023

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.

Interventions

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

Arms, Groups and Cohorts

• Placebo Comparator: Placebo
  • Placebo 8-week daily administration
• Active Comparator: Multistrain probiotic
  • Dietary Supplement: Multistrain Probiotic 12-week daily administration

Clinical Trial Outcome Measures

Primary Measures

• Cold symptoms evaluation
  • Time Frame: 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 Measures

• Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
  • Time Frame: 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)
  • Time Frame: 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
  • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 44 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Università degli Studi di Ferrara
• Provider of Information About this Clinical Study
  • Principal Investigator: Giacomo Caio, Professor – Università degli Studi di Ferrara
• Overall Contact(s)
  • Giacomo Caio, MD, PhD, +390532236823, caigmp@unife.it