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

NCT07091955 | Completed

• 1 other identifier: IRESP.PROB
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

URTI - Viral Upper Respiratory Tract Infection; Prevention

Keywords

upper respiratory tract infections; prevention; probiotics; microbiota; microbiome

Outcome Measures

Primary Outcomes (3)

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

  Difference in the proportion of patients who were diagnosed with at least 1, 2 or 3 URTIs during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups

  16 weeks

• Number of URTIs per patient

  Difference in the mean number of URTIs per patient between the study groups during the intervention period (12 weeks) and follow-up period (16 weeks)

  16 weeks

• Patients who were diagnosed of common cold and influenza

  Difference in the proportion of patients who were diagnosed of common cold and influenza during the intervention (12 weeks) and follow-up period (16 weeks) between the study groups.

  16 weeks

Secondary Outcomes (14)

• Participants who presented URTI complications

  16 weeks

• Number of URTI complications

  16 weeks

• Number of days until the occurrence of the first URTI episode

  12 weeks

• Number of days with URTI episode per participant

  16 weeks

• Duration of URTI episode

  16 weeks

Other Outcomes (1)

• Incidence and severity of Adverse Events

  16 weeks

Study Arms (2)

Lacticaseibacillus rhamnosus CRL1505

EXPERIMENTAL

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

Dietary Supplement: Lacticaseibacillus rhamnosus CRL1505

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Comparator

Interventions

Lacticaseibacillus rhamnosus CRL1505 DIETARY_SUPPLEMENT

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

Lacticaseibacillus rhamnosus CRL1505

Placebo Comparator DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women between 18 and 65 years.
• Signed Informed Consent to participate in the study
• BMI less than 35 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioithas SL: lead
• Centro Sperimentale del Latte S.r.l.: collaborator

Study Sites (1)

Universidad Católica San Antonio de Murcia (UCAM)

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Valentina Taverniti, Microbes & Health R&D Leader

  Centro Sperimentale del Latte S.r.l.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled with parallel assignment

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 29, 2025
• Study Start: October 16, 2023
• Primary Completion: February 27, 2024
• Study Completion: February 27, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)