Upper Respiratory Tract InfectionNCT07154992
Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children
A study testing Probiotic - Lacticaseibacillus rhamnosus CRL1505 in people with Upper Respiratory Tract Infection and Prevention, run by Bioithas SL at 1 site in Spain.
Trial 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 paediatric population. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection, Prevention
- What is being tested?
- Probiotic - Lacticaseibacillus rhamnosus CRL1505
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteSpain
- Study dates
- 17 Dec 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 3 to 12 years.
- Signed Informed Consent by the parents
Who cannot join
- Chronic pathological conditions, such as chronic respiratory diseases (asthma, chronic bronchitis, etc.), chronic heart diseases, chronic neurological diseases (psychomotor impairment, etc.), chronic liver diseases, chronic kidney diseases, chronic gastrointestinal diseases, hematological disorders, etc., or any other disease or condition that the investigator considers to significantly affect the health of the participating child.
- Metabolic disorders, such as diabetes mellitus, obesity, etc.
- Immunodeficiency, including HIV infection, chronic corticosteroid treatment, etc.
- Nasal polyps, nasal ulcers, or other conditions that may cause nasal obstruction.
- Regular use of medications or dietary supplements that may influence the study outcomes (immunosuppressants/immunostimulants, including echinacea supplements, analgesics, anti-inflammatory drugs, antitussives/expectorants, flu preparations, decongestants, antibiotics, antihistamines, probiotics, etc.) within the 4 weeks prior to the start of the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
MiBioPath Research Group (UCAM)
Murcia
Vicente Navarro López, +34865780170, vicente.navarro@bioithas.com
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in a Healthy Paediatric Population
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 paediatric population.
Read the 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 paediatric population.
The clinical trial has an intervention period of 12 weeks and a post-treatment follow-up period of 4 additional weeks (16 weeks in total).
The study aims to demonstrate the efficacy and safety of consuming the probiotic strain Lacticaseibacillus rhamnosus CRL1505 in the prevention and reduction of the severity and duration of URTI (upper respiratory tract infections) episodes in a healthy paediatric population.
A total of 268 participants aged 3 to 12 years will be recruited and randomized into two treatment groups in a 1:1 ratio (134 participants in the PROBIOTIC GROUP and 134 participants in the PLACEBO GROUP). The two intervention groups will differ based on the treatment received: probiotic or placebo, both of which will have a similar appearance.
The study will focus on a healthy paediatric population; therefore, the exclusion criteria will eliminate children with significant acute or chronic diseases and those with an immunocompromised condition. Additionally, children receiving continuous pharmacological treatment or those who have consumed dietary supplements that could influence the study results within the four weeks prior to inclusion will be excluded. However, if these children can discontinue such treatments, they may participate in the clinical trial after a washout period. Continuous regular medication that is deemed not to influence the study outcomes regarding the efficacy of the investigational product will be allowed.
Participants will be required not to modify their diet or physical activity during the course of the study.
The inclusion process will take place during winter months, to ensure that the study coincides with the months of highest URTI incidence.
Since this clinical trial will be conducted in minors, continuous evaluation will be the responsibility of the parents. They will be instructed to complete an online questionnaire daily, which will allow data collection to assess the efficacy and safety variables.
- Conditions
- Upper Respiratory Tract Infection, Prevention
- Being tested
- Probiotic - Lacticaseibacillus rhamnosus CRL1505, Placebo
- Keywords
- prevention, upper respiratory tract infections, probiotics, microbiota, microbiome, children
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - Lacticaseibacillus rhamnosus CRL1505Dietary supplement
The probiotic product is provided in 2g sticks containing the strain Lacticaseibacillus rhamnosus CRL1505 at a concentration of ≥ 1.0E+8 CFU/g, with corn starch and maltodextrin as excipients.
PlaceboDietary supplement
The placebo product is provided in 2g sticks of corn starch and maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| PROBIOTIC | Experimental | Not described Receives: Dietary Supplement: Probiotic - Lacticaseibacillus rhamnosus CRL1505 |
| PLACEBO | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 and 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)
Measured: 12 and 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.
*This analysis will only be performed if a considerable number of URTIs other than the common cold are recorded.
Measured: 12 and 16 weeks
Secondary outcomes (13)
Participants who presented URTI complications
Difference in the proportion of participants who experienced URTI complications (bacterial superinfections such as pneumonia, otitis media, and acute sinusitis) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Number of days with a URTI episode per participant
Difference in the average number of days with a URTI episode per participant (days with URTI/participants) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Number of days until the first URTI
Difference in the average number of days until the onset of the first URTI episode during the intervention period (12 weeks) between the study groups.
Measured: 12 weeks
Duration of each URTI episode
Difference in the average duration of each URTI episode (mean ratio of days with URTI/URTI episodes for each participant) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
URTI-free time rate
Difference in the URTI-free time rate (proportion of accumulated days in which participants do not experience URTI relative to the total number of days) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Score of each symptom evaluated on the Jackson scale
Difference in the average score of each symptom evaluated on the Jackson scale per day of common cold episode during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
The Jackson scale (also known as Jackson criteria or Jackson score) is a tool used to assess and quantify the symptoms of upper respiratory tract infections (URTI), such as the common cold
It evaluates 8 main symptoms:
Sneezing, Nasal discharge (runny nose), Nasal congestion, Sore throat, Cough, Headache, Malaise, Chilliness/feverishness
Each symptom is scored on a 0-3 scale:
0 = absent
- = mild
- = moderate
- = severe
Criteria for defining a "cold episode" (URTI case) according to Jackson:
At least 2 consecutive days with ≥2 of the following symptoms: runny nose, sore throat, sneezing. Or 1 of these symptoms plus at least one systemic symptom (headache, malaise, chilliness/feverishness).
Measured: 12 and 16 weeks
Number of days with fever per participant
Difference in the average number of days with fever per participant during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Participants who received antibiotic treatment
Difference in the proportion of participants who received antibiotic treatment during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Number of days with antibiotic treatment per participant
Difference in the average number of days with antibiotic treatment per participant during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Proportion of URTI episodes in which participants received symptomatic medication
Difference in the proportion of URTI episodes in which participants received symptomatic medication (to relieve URTI symptoms) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Proportion of URTI days in which participants received symptomatic medication
Difference in the proportion of URTI days in which participants received symptomatic medication (to relieve URTI symptoms) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Participants who experienced gastrointestinal infections
Difference in the proportion of participants who experienced gastrointestinal infections during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
School absence rate
Difference in the school absence rate (proportion of accumulated school absence days due to URTI relative to the total number of days) during the intervention period (12 weeks) and the total follow-up period (16 weeks) between the study groups.
Measured: 12 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start17 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Sperimentale del Latte S.r.l.
- Responsible party
- Sponsor
- Investigators
- Valentina Taverniti, Study director, Microbes & Health R&D Leader, Centro Sperimentale del Latte S.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154992
- Sponsor's protocol ID
- IRESP.PROB-2
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in a Healthy Paediatric Population
- ClinicalTrials.gov ID
- NCT07154992
- Acronym / sponsor ID
- IRESP.PROB-2
- Conditions
- Upper Respiratory Tract Infection, Prevention
- Keywords
- prevention, upper respiratory tract infections, probiotics, microbiota, microbiome, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Collaborators
- Centro Sperimentale del Latte S.r.l.
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 paediatric 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 paediatric population.
The clinical trial has an intervention period of 12 weeks and a post-treatment follow-up period of 4 additional weeks (16 weeks in total).
The study aims to demonstrate the efficacy and safety of consuming the probiotic strain Lacticaseibacillus rhamnosus CRL1505 in the prevention and reduction of the severity and duration of URTI (upper respiratory tract infections) episodes in a healthy paediatric population.
A total of 268 participants aged 3 to 12 years will be recruited and randomized into two treatment groups in a 1:1 ratio (134 participants in the PROBIOTIC GROUP and 134 participants in the PLACEBO GROUP). The two intervention groups will differ based on the treatment received: probiotic or placebo, both of which will have a similar appearance.
The study will focus on a healthy paediatric population; therefore, the exclusion criteria will eliminate children with significant acute or chronic diseases and those with an immunocompromised condition. Additionally, children receiving continuous pharmacological treatment or those who have consumed dietary supplements that could influence the study results within the four weeks prior to inclusion will be excluded. However, if these children can discontinue such treatments, they may participate in the clinical trial after a washout period. Continuous regular medication that is deemed not to influence the study outcomes regarding the efficacy of the investigational product will be allowed.
Participants will be required not to modify their diet or physical activity during the course of the study.
The inclusion process will take place during winter months, to ensure that the study coincides with the months of highest URTI incidence.
Since this clinical trial will be conducted in minors, continuous evaluation will be the responsibility of the parents. They will be instructed to complete an online questionnaire daily, which will allow data collection to assess the efficacy and safety variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROBIOTIC | Experimental | Dietary Supplement: Probiotic - Lacticaseibacillus rhamnosus CRL1505 |
| PLACEBO | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children aged 3 to 12 years.
- Signed Informed Consent by the parents
Key exclusion criteria (5 listed)
- Chronic pathological conditions, such as chronic respiratory diseases (asthma, chronic bronchitis, etc.), chronic heart diseases, chronic neurological diseases (psychomotor impairment, etc.), chronic liver diseases, chronic kidney diseases, chronic gastrointestinal diseases, hematological disorders, etc., or any other disease or condition that the investigator considers to significantly affect the health of the participating child.
- Metabolic disorders, such as diabetes mellitus, obesity, etc.
- Immunodeficiency, including HIV infection, chronic corticosteroid treatment, etc.
- Nasal polyps, nasal ulcers, or other conditions that may cause nasal obstruction.
- Regular use of medications or dietary supplements that may influence the study outcomes (immunosuppressants/immunostimulants, including echinacea supplements, analgesics, anti-inflammatory drugs, antitussives/expectorants, flu preparations, decongestants, antibiotics, antihistamines, probiotics, etc.) within the 4 weeks prior to the start of the clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic - Lacticaseibacillus rhamnosus CRL1505The probiotic product is provided in 2g sticks containing the strain Lacticaseibacillus rhamnosus CRL1505 at a concentration of ≥ 1.0E+8 CFU/g, with corn starch and maltodextrin as excipients. | Dietary supplement | PROBIOTIC |
| PlaceboThe placebo product is provided in 2g sticks of corn starch and maltodextrin. | Dietary supplement | PLACEBO |
Primary outcome
Patients who were diagnosed with at least 1, 2 or 3 URTIs
Time frame: 12 and 16 weeks
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
Number of URTIs per patient
Time frame: 12 and 16 weeks
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)
Patients who were diagnosed of common cold and influenza
Time frame: 12 and 16 weeks
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. *This analysis will only be performed if a considerable number of URTIs other than the common cold are recorded.
13 secondary outcomes
Participants who presented URTI complications
Time frame: 12 and 16 weeks
Number of days with a URTI episode per participant
Time frame: 12 and 16 weeks
Number of days until the first URTI
Time frame: 12 weeks
Duration of each URTI episode
Time frame: 12 and 16 weeks
URTI-free time rate
Time frame: 12 and 16 weeks
Score of each symptom evaluated on the Jackson scale
Time frame: 12 and 16 weeks
Number of days with fever per participant
Time frame: 12 and 16 weeks
Participants who received antibiotic treatment
Time frame: 12 and 16 weeks
Number of days with antibiotic treatment per participant
Time frame: 12 and 16 weeks
Proportion of URTI episodes in which participants received symptomatic medication
Time frame: 12 and 16 weeks
Proportion of URTI days in which participants received symptomatic medication
Time frame: 12 and 16 weeks
Participants who experienced gastrointestinal infections
Time frame: 12 and 16 weeks
School absence rate
Time frame: 12 and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentina Taverniti study director
Microbes & Health R&D Leader, Centro Sperimentale del Latte S.r.l.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic - Lacticaseibacillus rhamnosus CRL1505 in people with Upper Respiratory Tract Infection and Prevention, run by Bioithas SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Gabriel Agüera Santos (+34623022586, juan.aguera@bioithas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who were diagnosed with at least 1, 2 or 3 URTIs (time frame: 12 and 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.