Airways Allergic Inflammation of Asthmatic ChildrenNCT01241084
Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on Asthmatic Children
A study testing Antileukotrienes + Lactobacillus reuteri in people with Airways Allergic Inflammation of Asthmatic Children, run by Federico II University at 1 site in Italy.
Trial summary
Objective The aim of the trial is to evaluate the beneficial effects of the oral administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation in children with mild to moderate persistent asthma. Study design This is a randomized, double-blind, placebo controller trial. Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Airways Allergic Inflammation of Asthmatic Children
- What is being tested?
- Antileukotrienes + Lactobacillus reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Jun 2011
- 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with age range 6-14 years
- Informed consent signed
Who cannot join
- Participation to other clinical trials
- Informed consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on the Airways Allergic Inflammation of Asthmatic Children
Objective The aim of the trial is to evaluate the beneficial effects of the oral administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation in children with mild to moderate persistent asthma.
Study design This is a randomized, double-blind, placebo controller trial. 50 children will be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.
Read more
Patients will be randomly divided into 2 treatment groups:
Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).
Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis.
During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3.
All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit "Michele Miraglia del Giudice" of the "F. Fede" Pediatric Department.
The analysis of the inflammatory markers on the exhaled condensate will be performer at T1, T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.
During the trial it will be possible to administer only salbutamole MDI if it needed. If patients will be administered with any systemic corticosteroids they will exit from the trial.
At the enrolment period all patients will receive the completed information on the trial and the informed consent will be properly signed.
- Being tested
- Antileukotrienes + Lactobacillus reuteri, Antileukotrienes + Placebo
- Keywords
- asthmatic children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antileukotrienes + Lactobacillus reuteriDietary supplement
Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months
Antileukotrienes + PlaceboDietary supplement
Montelukast (5mg/die) + 5 drops of placebo daily for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Antileukotrienes+Placebo Receives: Dietary Supplement: Antileukotrienes + Placebo |
| Lactobacillus reuteri | Active comparator | Antileukotrienes+Lactobacillus reuteri Receives: Dietary Supplement: Antileukotrienes + Lactobacillus reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beneficial effects of Lactobacillus reuteri supplementation on asthmatic children
At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. .
At the enrolment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis.
During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airways Allergic Inflammation of Asthmatic ChildrenStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michele Miraglia del Giudice, Federico II University
- Investigators
- Michele Miraglia del Giudice, MD, Principal investigator, AOU "Federico II" di Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241084
- Sponsor's protocol ID
- Lr_Asthma
- Status last verified
- Sep 2011
- First submitted
- 15 Nov 2010
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Lactobacillus Reuteri DSM 17938 Supplementation on the Airways Allergic Inflammation of Asthmatic Children
- ClinicalTrials.gov ID
- NCT01241084
- Acronym / sponsor ID
- Lr_Asthma
- Keywords
- asthmatic children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Nov 2010 (estimated)
- 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.
Objective The aim of the trial is to evaluate the beneficial effects of the oral administration of the probiotic L. Reuteri (Reuterin®) on the airways allergic inflammation in children with mild to moderate persistent asthma.
Study design This is a randomized, double-blind, placebo controller trial. 50 children will be enrolled (age range 6-14 years), affected by mild to moderate persistent asthma based on the GINA Guidelines and allergic to acarus (Dermatophagoides farinae and D. pteronyssinus ++/+++). At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. Any inhaling corticosteroids therapies have to be stopped 8 weeks before the trial beginning.
Patients will be randomly divided into 2 treatment groups:
Group A: 25 patients will take antileukotrienes + L. reuteri drops (108 CFU = 5 drops daily).
Group B: 25 patients will take antileukotrienes + placebo. At the enrollment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis.
During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3.
All children will be enrolled at the Asthma and Infant Respiratory Physiopathology unit "Michele Miraglia del Giudice" of the "F. Fede" Pediatric Department.
The analysis of the inflammatory markers on the exhaled condensate will be performer at T1, T2 and T3 in the Pharmacology unit of the Experimental Medicine Department.
During the trial it will be possible to administer only salbutamole MDI if it needed. If patients will be administered with any systemic corticosteroids they will exit from the trial.
At the enrolment period all patients will receive the completed information on the trial and the informed consent will be properly signed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Antileukotrienes + PlaceboAntileukotrienes+Placebo |
| Lactobacillus reuteri | Active comparator | Dietary Supplement: Antileukotrienes + Lactobacillus reuteriAntileukotrienes+Lactobacillus reuteri |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with age range 6-14 years
- Informed consent signed
Key exclusion criteria (2 listed)
- Participation to other clinical trials
- Informed consent not signed
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 |
|---|---|---|
| Antileukotrienes + Lactobacillus reuteriMontelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months | Dietary supplement | Lactobacillus reuteri |
| Antileukotrienes + PlaceboMontelukast (5mg/die) + 5 drops of placebo daily for 2 months | Dietary supplement | Placebo |
Primary outcome
Beneficial effects of Lactobacillus reuteri supplementation on asthmatic children
Time frame: two months
At the enrollment period all children have to show asthmatic symptoms and to be under antileukotrienes treatment (Montelukast 5mg/die) based on the GINA Guidelines. . At the enrolment period (T0), after the 1st and the 2nd month of supplementation (T1 and T2), and also 1 month after the supplementation end (T3), all patients will be clinically evaluated through spirometry, FeNO determination and exhale condensate analysis. During the entire trial period the number of asthmatic exacerbations and the use of beta-2 antagonists will be monitored by a diary properly examined at T1, T2 and T3.
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 3 Oct 2011.
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.
Michele Miraglia del Giudice, MD principal investigator
AOU "Federico II" di Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antileukotrienes + Lactobacillus reuteri in people with Airways Allergic Inflammation of Asthmatic Children, run by Federico II University 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 2 inclusion and 2 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 3 Oct 2011. 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?
Beneficial effects of Lactobacillus reuteri supplementation on asthmatic children (time frame: two months). 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 3 Oct 2011.