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

Last updated: December 3, 2024
Sponsor: Università degli Studi di Ferrara
Overall Status: Completed

Phase

N/A

Condition

Common Cold

Treatment

Placebo

DefensePlus

Clinical Study ID

NCT05656729
ImmunoCold 2021
  • Ages 18-44
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

people who:

  • are willing and capable of joining the study

  • are willing of not varying their routine (lifestyle, physical activity..) during thestudy

  • 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

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, renaldisease, 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 cerebralfunctioning impairment

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 22, 2022
Estimated Completion Date:
July 30, 2024

Study 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.

Connect with a study center

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124
    Italy

    Site Not Available

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