ImmunomodulationNCT06218225
Effect of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections
A study testing Verum in people with Immunomodulation and Respiratory Tract; Infection, Upper (Acute), run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of the product in developing immune reinforcement that results in decreased susceptibility to respiratory infections of viral origin in children aged 3 to 10 years with a number of respiratory tract infectious events in the previous year greater than 4. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunomodulation, Respiratory Tract; Infection, Upper (Acute)
- What is being tested?
- Verum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both sexes children aged 3-10 years, with a number of respiratory tract infectious events in the previous year greater than 4.
Who cannot join
- Acute upper respiratory tract or other infection within 7 days prior to enrollment, cystic fibrosis, immunodeficiency syndromes, abnormalities respiratory tract anatomy, use of immunostimulant drugs or immunosuppressants in the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effects of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections
The goal of this clinical trial is to evaluate the efficacy of the product in developing immune reinforcement that results in decreased susceptibility to respiratory infections of viral origin in children aged 3 to 10 years with a number of respiratory tract infectious events in the previous year greater than 4. The main questions it aims to answer are:
- Has the number of infectious events been reduced from last year?
- Does the severity of symptoms decrease with the use of the product?
Read more
Participants will be treated for 4 months. Treatment efficacy will be evaluated by:
- 2 scheduled visits with the investigating pediatrician (T0 - enrollment and start of treatment; T1- end of treatment).
- Verification of progress during the study by scheduled telephone meetings.
- The use of a diary where the patient or parent/caregiver will report all events (even mild) affecting the respiratory tract, taking care to fully complete the Wisconsin Upper Respiratory Symptom Survey for kids (WURSS-k) questionnaire.
Read the detailed description
The immune system is a complex network consisting of organs, tissues, cells and the substances they produce. It has the function of protecting the body from external agents (including infectious agents) by activating three different types of response: the innate response, the adaptive response, and the mechanical or chemical response. The innate and adaptive response are activated together, one modulating the other. The innate or natural response represents a first line of defense. The adaptive or specific response is a slower but more powerful and targeted defensive response and enables the creation of immunological memory.
In the pediatric setting in the early months, and in the later first years of life, where the "immunological memory" has not yet strengthened, infectious events such as fever, flu, colds, throat discomfort, cough, respiratory infections, sore throat, various respiratory tract ailments, gastrointestinal diseases or related only to the intestinal tract occur frequently. It will take time for it to strengthen, and for the little one to be immune to a bacterial infection, but there are remedies to help. A healthy lifestyle, physical activity and a balanced diet that allows the right amount of protein, vitamins and minerals can strengthen the immune system. In some cases, where healthy diet and lifestyle needed support, the use of natural substances with immune-stimulating action proves useful.
The tested product is a dietary supplement specifically designed to modulate immune defenses in children. It contains the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus CRL1505. Zinc and vitamins B6, B12, C, and D contribute to normal immune system function. Elderberry and acerola support the body's natural defenses. Lactobacillus rhamnosus CRL1505 is a probiotic that promotes the balance of the flora intestinal flora. Several clinical studies have shown that it can reduce the incidence of pediatric infections, including respiratory tract infections.
The goal of this clinical trial is to evaluate the efficacy of the product in developing immune reinforcement that results in decreased susceptibility to respiratory infections of viral origin in children aged 3 to 10 years with a number of respiratory tract infectious events in the previous year greater than 4.
Treatment consists of taking one single-dose bottle daily for a total of 4 months as follows:
1st cycle - 30 days use of study product or placebo Cycle 2 - first 15 days washout, remaining 15 days use of study product or placebo Cycle 3 - first 15 days washout, remaining 15 days use of study product or placebo 4th cycle - 30-day washout Numerosity and severity of infectious events will be assessed during meetings with the pediatrician and through a diary where the patient or parent/caregiver will report all events (even mild) affecting the respiratory tract, taking care to fully complete the Wisconsin Upper Respiratory Symptom Survey for kids (WURSS-k) questionnaire.
- Being tested
- Verum, Placebo
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerumDietary supplement
1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of study product Cycle 3 - first 15 days washout, remaining 15 days use of study product 4th cycle - 30-day washout
PlaceboDietary supplement
1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of placebo Cycle 3 - first 15 days washout, remaining 15 days use of placebo 4th cycle - 30-day washout
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Partecipants received a food supplement with the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus CRL1505. Receives: Dietary Supplement: Verum |
| Placebo | Placebo comparator | Partecipants received a food supplement in the same primary packaging of the verum, but without active substances Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the reduction in the severity of symptoms related to Acute Respiratory Tract Infections
Evaluation of the reduction of illness-specific symptoms during an ARI by means of validated 15-items questionnaire (WURSS-k)
Measured: For each infectious event, it should be filled in on the first day of symptoms, on the third day of symptoms, and if symptoms persist, it should also be filled in on the seventh day of symptoms.
Secondary outcomes (1)
Evaluation of the reduction in the number of Acute Respiratory Tract Infections
Evaluation of the reduction in the number of infectious events during the 4-months study duration, based on how many times each patient completed the WURSS-k questionnaire
Measured: T0 (first visit), T1 (4 months later - end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start15 Oct 2022
- Primary completion31 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunomodulationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind verum vs placebo
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218225
- Sponsor's protocol ID
- IMMUNOJR
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. 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 Effects of an Immune-boosting Food Supplement on the Severity and Frequency of Pediatric Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT06218225
- Acronym / sponsor ID
- IMMUNOJR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 23 Jan 2024 (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.
The goal of this clinical trial is to evaluate the efficacy of the product in developing immune reinforcement that results in decreased susceptibility to respiratory infections of viral origin in children aged 3 to 10 years with a number of respiratory tract infectious events in the previous year greater than 4. The main questions it aims to answer are:
- Has the number of infectious events been reduced from last year?
- Does the severity of symptoms decrease with the use of the product?
Participants will be treated for 4 months. Treatment efficacy will be evaluated by:
- 2 scheduled visits with the investigating pediatrician (T0 - enrollment and start of treatment; T1- end of treatment).
- Verification of progress during the study by scheduled telephone meetings.
- The use of a diary where the patient or parent/caregiver will report all events (even mild) affecting the respiratory tract, taking care to fully complete the Wisconsin Upper Respiratory Symptom Survey for kids (WURSS-k) questionnaire.
Detailed description
The immune system is a complex network consisting of organs, tissues, cells and the substances they produce. It has the function of protecting the body from external agents (including infectious agents) by activating three different types of response: the innate response, the adaptive response, and the mechanical or chemical response. The innate and adaptive response are activated together, one modulating the other. The innate or natural response represents a first line of defense. The adaptive or specific response is a slower but more powerful and targeted defensive response and enables the creation of immunological memory.
In the pediatric setting in the early months, and in the later first years of life, where the "immunological memory" has not yet strengthened, infectious events such as fever, flu, colds, throat discomfort, cough, respiratory infections, sore throat, various respiratory tract ailments, gastrointestinal diseases or related only to the intestinal tract occur frequently. It will take time for it to strengthen, and for the little one to be immune to a bacterial infection, but there are remedies to help. A healthy lifestyle, physical activity and a balanced diet that allows the right amount of protein, vitamins and minerals can strengthen the immune system. In some cases, where healthy diet and lifestyle needed support, the use of natural substances with immune-stimulating action proves useful.
The tested product is a dietary supplement specifically designed to modulate immune defenses in children. It contains the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus CRL1505. Zinc and vitamins B6, B12, C, and D contribute to normal immune system function. Elderberry and acerola support the body's natural defenses. Lactobacillus rhamnosus CRL1505 is a probiotic that promotes the balance of the flora intestinal flora. Several clinical studies have shown that it can reduce the incidence of pediatric infections, including respiratory tract infections.
The goal of this clinical trial is to evaluate the efficacy of the product in developing immune reinforcement that results in decreased susceptibility to respiratory infections of viral origin in children aged 3 to 10 years with a number of respiratory tract infectious events in the previous year greater than 4.
Treatment consists of taking one single-dose bottle daily for a total of 4 months as follows:
1st cycle - 30 days use of study product or placebo Cycle 2 - first 15 days washout, remaining 15 days use of study product or placebo Cycle 3 - first 15 days washout, remaining 15 days use of study product or placebo 4th cycle - 30-day washout Numerosity and severity of infectious events will be assessed during meetings with the pediatrician and through a diary where the patient or parent/caregiver will report all events (even mild) affecting the respiratory tract, taking care to fully complete the Wisconsin Upper Respiratory Symptom Survey for kids (WURSS-k) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized double blind verum vs placebo
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: VerumPartecipants received a food supplement with the innovative IMMUREMEDY®-B complex and Lactobacillus rhamnosus CRL1505. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPartecipants received a food supplement in the same primary packaging of the verum, but without active substances |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Both sexes children aged 3-10 years, with a number of respiratory tract infectious events in the previous year greater than 4.
Key exclusion criteria (1 listed)
- Acute upper respiratory tract or other infection within 7 days prior to enrollment, cystic fibrosis, immunodeficiency syndromes, abnormalities respiratory tract anatomy, use of immunostimulant drugs or immunosuppressants in the previous 4 weeks.
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 |
|---|---|---|
| Verum1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of study product Cycle 3 - first 15 days washout, remaining 15 days use of study product 4th cycle - 30-day washout | Dietary supplement | Verum |
| Placebo1st cycle - 30 days continuous use Cycle 2 - first 15 days washout, remaining 15 days use of placebo Cycle 3 - first 15 days washout, remaining 15 days use of placebo 4th cycle - 30-day washout | Dietary supplement | Placebo |
Primary outcome
Evaluation of the reduction in the severity of symptoms related to Acute Respiratory Tract Infections
Time frame: For each infectious event, it should be filled in on the first day of symptoms, on the third day of symptoms, and if symptoms persist, it should also be filled in on the seventh day of symptoms.
Evaluation of the reduction of illness-specific symptoms during an ARI by means of validated 15-items questionnaire (WURSS-k)
1 secondary outcome
Evaluation of the reduction in the number of Acute Respiratory Tract Infections
Time frame: T0 (first visit), T1 (4 months later - end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum in people with Immunomodulation and Respiratory Tract; Infection, Upper (Acute), run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Feb 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the reduction in the severity of symptoms related to Acute Respiratory Tract Infections (time frame: For each infectious event, it should be filled in on the first day of symptoms, on the third day of symptoms, and if symptoms persist, it should also be filled in on the seventh day of symptoms.). 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 1 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.