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

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

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

Study Overview

• Status: Completed
• Conditions: Cold Symptom
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: DefensePlus

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Azienda Ospedaliero Universitaria Di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: probiotics; cold; cold symptoms
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Diseases; Pharyngeal Diseases; Pharyngitis; Nasopharyngitis
• Other Study ID Numbers: ImmunoCold 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No