CompletedNot Applicable

Clinical Trial to Evaluate the Efficacy of a Probiotic Preparation in the Prevention of Upper Respiratory Tract Infections in Adults

Spain140 participantsStarted 2023-10-16

Plain-language summary

Randomized, double-blind, placebo-controlled, parallel-group, clinical trial to assess the efficacy of the intake of a probiotic product composed of Lacticaseibacillus rhamnosus CRL1505 strain in reducing or preventing upper respiratory tract infections (URTIs) in a healthy adult population

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy men and women between 18 and 65 years. * Signed Informed Consent to participate in the study * BMI less than 35 kg/m2 Exclusion Criteria: * Chronic pathological conditions such as chronic respiratory diseases (asthma, chronic bronchitis, chronic obstructive pulmonary disease etc), chronic heart diseases (chronic heart failure etc), chronic neurological diseases (Parkinson´s diseases, multiple esclerosis etc), chronic liver diseases, kidney liver diseases, gastrointestinal diseases, hematologic disorders etc, or other disease or condition that the researcher considers * Metabolic disorders (diabetes, obesity with BMI greater than 35.1 kg/m2 etc). * Congenital or acquired immune defects (including allergies). * Immunocompromised individuals (HIV infection, chemotherapy, post-trasplant, chronic corticosteroid treatment etc). * Presence of nasal ulcers/nasal polyps or other conditions that could cause nasal obstruction. * Abuse of alcohol, tobacco or other drugs. * Pregnancy or lactation. * Regular intake of products that could influence the study outcome (immune suppressants/immune stimulants including paramedication such as Echinacea, analgesics, antiinflammatories, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, antihistaminergic drugs, probiotics) within the last 4 weeks prior to the study start. * Influenza vaccination in the last 6 monts.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patients who were diagnosed with at least 1, 2 or 3 URTIs

Timeframe: 16 weeks

Number of URTIs per patient

Timeframe: 16 weeks

Patients who were diagnosed of common cold and influenza

Timeframe: 16 weeks

Trial details

NCT IDNCT07091955

SponsorBioithas SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-27

View on ClinicalTrials.gov More URTI - Viral Upper Respiratory Tract Infection trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.