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

Università degli Studi di Ferrara

Status: Completed

Conditions: Cold Symptom

Treatments: Dietary Supplement: Placebo; Dietary Supplement: DefensePlus

Study type: Interventional

Funder types: Other

Identifiers

NCT05656729

ImmunoCold 2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 8-week daily administration

Treatment:

Dietary Supplement: Placebo

Multistrain probiotic

Active Comparator group

Description:

Dietary Supplement: Multistrain Probiotic 12-week daily administration

Treatment:

Dietary Supplement: DefensePlus