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

NCT ID: NCT07091955

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-02-27

Brief 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

Detailed Description

Randomized, double-blind, placebo-controlled, parallel-group, clinical trial. The study aims to demonstrate the efficacy of the intake of a probiotic product composed of Lacticaseibacillus rhamnosus CRL1505 strain in reducing or preventing upper respiratory tract infections in a healthy adult population.

The study will be focused on a healthy population, so the exclusion criteria will rule out individuals with major acute or chronic illnesses and an immunocompromised state. In addition, those subjects with a regular pharmacological treatment or consumption of food supplements that could influence the outcome of the study in the last 4 weeks prior to inclusión will be excluded. If patients could discontinue this treatment after a washout period and during the intervention period, they would be able to participate in the study. However, the usual medication that is considered not to influence the results of the study will be allowed. Subjects recently vaccinated against influenza will also be excluded, but as the study focuses on a healthy population, a priori vaccination is not recommended and there would be no problem in finding subjects with these characteristics because there is no contradiction.

In addition, subjects included will be asked not to modify their diet or physical activity during the study.

An important data that is not usually recorded in many studies is the use of medication to alleviate the symptoms of URTI, either non-prescription or prescribed by the physician. Only antibiotic medication to treat or prevent bacterial upper respiratory tract coinfections or complications is usually established as a variable (the use of antibiotics is established as a secondary variable in the present study). The investigators consider that it is very important to record the use of these treatments to evaluate if any study group is unbalanced in this regard and/or whether it is a confusion factor when interpreting the results. The investigators could consider the possibility of performing a post hoc analysis of this topic and present it in the final report if the results are interesting.

Similarly, it is important to collect baseline data related to the type of work or continuous contact with people with risk factors such as children or elderly to assess whether the groups are balanced. It will also be collected data about the number of URTIs in the study subjects since 3 months prior to inclusion.

The treatment period will be 12 weeks. There will then be a follow-up period (without treatment) of 4 weeks to evaluate the sustained effect of the probiotic product. The study will be structured in 3 face-to-face visits at week 0, 12 and 16.

For the evaluation of the efficacy variables, a diary would be provided to the study subject for a daily evaluation. Saliva collection kits for the determination of salivary IgA in the initial o final visits will also be provided.

The complete inclusion process will be carried out in October and November so that the study was located in the months of highest URTI incidence.

Conditions

URTI - Viral Upper Respiratory Tract Infection; Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Lacticaseibacillus rhamnosus CRL1505

Probiotic product containing Lacticaseibacillus rhamnosus CRL1505 formulated in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Group Type: EXPERIMENTAL

Lacticaseibacillus rhamnosus CRL1505

Intervention Type: DIETARY_SUPPLEMENT

Probiotic product containing Lacticaseibacillus rhamnosus CRL1505 formulated in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Placebo

Placebo product containing cornstarch, in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DIETARY_SUPPLEMENT

Placebo product containing cornstarch, in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Interventions

Lacticaseibacillus rhamnosus CRL1505

Probiotic product containing Lacticaseibacillus rhamnosus CRL1505 formulated in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Intervention Type: DIETARY_SUPPLEMENT

Placebo Comparator

Placebo product containing cornstarch, in a vegetable hydroxymethylpropyl-cellulose capsule of size 2

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Sperimentale del Latte S.r.l.

UNKNOWN

Sponsor Role: collaborator

Bioithas SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valentina Taverniti, Microbes & Health R&D Leader

Role: STUDY_DIRECTOR

Centro Sperimentale del Latte S.r.l.

Locations

Universidad Católica San Antonio de Murcia (UCAM)

Murcia, Murcia, Spain

Countries

Spain

Other Identifiers

IRESP.PROB

Identifier Type: -

Identifier Source: org_study_id