Back to resultsEffect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients With an History of Upper Airways Infection
Primary Purpose
Cold Symptom
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DefensePlus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cold Symptom focused on measuring cold, cold symptoms, probiotics
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
Sites / Locations
- Azienda Ospedaliero Universitaria di FerraraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Multistrain probiotic
Arm Description
Placebo 8-week daily administration
Dietary Supplement: Multistrain Probiotic 12-week daily administration
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT05656729
First Posted
December 5, 2022
Last Updated
January 13, 2023
Sponsor
Università degli Studi di Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT05656729
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Symptom
Keywords
cold, cold symptoms, probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 8-week daily administration
Arm Title
Multistrain probiotic
Arm Type
Active Comparator
Arm Description
Dietary Supplement: Multistrain Probiotic 12-week daily administration
Intervention Type
Dietary Supplement
Intervention Name(s)
DefensePlus
Intervention Description
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Primary Outcome Measure Information:
Title
Cold symptoms evaluation
Description
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
Description
Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms
Time Frame
18 weeks
Title
Change of Short Form Health Survey 36 (SF-36)
Description
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
Time Frame
18 weeks
Title
Inflammatory status
Description
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
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giacomo Caio, MD, PhD
Phone
+390532236823
Email
caigmp@unife.it
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Caio, MD, PhD
Phone
+390532236823
Email
caigmp@unife.it
12. IPD Sharing Statement
Learn more about this trial
Effect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients With an History of Upper Airways Infection
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