AsthmaPhase 3NCT02734446
To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
A Phase 3 study testing Reuterin D3 drops in people with Asthma, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- Reuterin D3 drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Mar 2016
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child
Who may be able to join
- Patients aged between 6 and 14 years old, of both sexes
- Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
- Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
- Levels of vitamin 25 (OH) D <30 ng / ml
- Signature of the informed consent of one parent or a legal representative
Who cannot join
- Cardiovascular disease or systemic
- anatomical abnormalities
- Other respiratory diseases
- Taking probiotics and / or prebiotics in the previous 2 weeks
- Taking vitamin D or systemic corticosteroids within 4 weeks
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .
Read the detailed description
To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).
- Conditions
- Asthma
- Being tested
- Reuterin D3 drops, Placebo
- Keywords
- Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT), Asthma Exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reuterin D3 dropsDrug
Also called Lactobacillus reuteri DSM 17938 + Vit. D3
5 drops/day for 3 months
PlaceboOther
5 drops/day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Reuterin D3 drops | Active comparator | Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops) Receives: Drug: Reuterin D3 drops |
| Placebo | Placebo comparator | The patients will receive 5 drops/day of placebo for 3 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of allergic bronchial inflammation
Reduction of FeNO values
Measured: Up to 3 months
Reduction of allergic bronchial inflammation
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.
Measured: Up to 3 months
Secondary outcomes (3)
Improvement of asthma control by C-ACT
Improvement in asthma control assessed by:
C-ACT (Scores > 19)
Measured: Up to 3 months
Improvement of asthma control by reduction of bronchodilator
Improvement in asthma control assessed by:
Reduction use of bronchodilator
Measured: Up to 3 months
Improvement of asthma control by improvement of FEV-1
Improvement in asthma control assessed by:
Improvement of Forced Expiratory Volume in 1 second (FEV-1)
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michele Miraglia del Giudice, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734446
- Sponsor's protocol ID
- RTN_D3
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Miraglia Del Giudice M, Maiello N, Allegorico A, Iavarazzo L, Capasso M, Capristo C, Ciprandi G. Lactobacillus reuteri DSM 17938 plus vitamin D3 as ancillary treatment in allergic children with asthma. Ann Allergy Asthma Immunol. 2016 Dec;117(6):710-712. doi: 10.1016/j.anai.2016.09.004. Epub 2016 Oct 6. No abstract available.
PubMed 27720582
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
- ClinicalTrials.gov ID
- NCT02734446
- Acronym / sponsor ID
- RTN_D3
- Conditions
- Asthma
- Keywords
- Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT), Asthma Exacerbations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Apr 2016 (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.
The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .
Detailed description
To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reuterin D3 drops | Active comparator | Drug: Reuterin D3 dropsLactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops) |
| Placebo | Placebo comparator | Other: PlaceboThe patients will receive 5 drops/day of placebo for 3 months |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients aged between 6 and 14 years old, of both sexes
- Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
- Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
- Levels of vitamin 25 (OH) D <30 ng / ml
- Signature of the informed consent of one parent or a legal representative
Key exclusion criteria (6 listed)
- Cardiovascular disease or systemic
- anatomical abnormalities
- Other respiratory diseases
- Taking probiotics and / or prebiotics in the previous 2 weeks
- Taking vitamin D or systemic corticosteroids within 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 |
|---|---|---|
| Reuterin D3 dropsAlso: Lactobacillus reuteri DSM 17938 + Vit. D35 drops/day for 3 months | Drug | Reuterin D3 drops |
| Placebo5 drops/day for 3 months | Other | Placebo |
Primary outcome
Reduction of allergic bronchial inflammation
Time frame: Up to 3 months
Reduction of FeNO values
Reduction of allergic bronchial inflammation
Time frame: Up to 3 months
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.
3 secondary outcomes
Improvement of asthma control by C-ACT
Time frame: Up to 3 months
Improvement of asthma control by reduction of bronchodilator
Time frame: Up to 3 months
Improvement of asthma control by improvement of FEV-1
Time frame: Up to 3 months
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 12 Apr 2016.
- Derived from this study: PubMed 27720582Miraglia Del Giudice M, Maiello N, Allegorico A, Iavarazzo L, Capasso M, Capristo C, Ciprandi G. Lactobacillus reuteri DSM 17938 plus vitamin D3 as ancillary treatment in allergic children with asthma. Ann Allergy Asthma Immunol. 2016 Dec;117(6):710-712. doi: 10.1016/j.anai.2016.09.004. Epub 2016 Oct 6. No abstract available.
- Individual participant dataSharing planned: Yes
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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 Phase 3 study testing Reuterin D3 drops in people with Asthma, run by University of Campania Luigi Vanvitelli 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 5 inclusion and 6 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 12 Apr 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of allergic bronchial inflammation (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734446, which also lists 1 linked publication.
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 Apr 2016.