Clinical Trial to Evaluate the Efficacy of a Probiotic Preparation in the Prevention of Upper Res… (NCT07091955) | Clinical Trial Compass
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 range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Patients who were diagnosed with at least 1, 2 or 3 URTIs
Timeframe: 16 weeks
2
Number of URTIs per patient
Timeframe: 16 weeks
3
Patients who were diagnosed of common cold and influenza