MedDataX Logo

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

NCT ID: NCT05656729

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cold Symptom

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cold cold symptoms probiotics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo 8-week daily administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Multistrain probiotic

Dietary Supplement: Multistrain Probiotic 12-week daily administration

Group Type ACTIVE_COMPARATOR

DefensePlus

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DefensePlus

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

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Exclusion Criteria

subjects:
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giacomo Caio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Ferrara, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ImmunoCold 2021

Identifier Type: -

Identifier Source: org_study_id