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NCT Number: NCT05656729

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

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

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Key information

Conditions

Cold Symptom Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DefensePlus

Dietary Supplement

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

Placebo

Dietary Supplement

Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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