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

NCT05656729 | Completed

• 1 other identifier: ImmunoCold 2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cold Symptom

Keywords

cold; cold symptoms; probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  18 weeks

• Change of Short Form Health Survey 36 (SF-36)

  18 weeks

• Inflammatory status

  18 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 8-week daily administration

Dietary Supplement: Placebo

Multistrain probiotic

ACTIVE COMPARATOR

Dietary Supplement: Multistrain Probiotic 12-week daily administration

Dietary Supplement: DefensePlus

Interventions

DefensePlus DIETARY_SUPPLEMENT

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

Multistrain probiotic

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• subjects:
• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Ferrara, 44124, Italy

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 19, 2022
• Study Start: December 22, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)