To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
1 other identifier
interventional
52
1 country
1
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Apr 2014
Typical duration for phase_3 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 12, 2016
CompletedApril 12, 2016
April 1, 2016
10 months
March 18, 2016
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction of allergic bronchial inflammation
Reduction of FeNO values
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.
Up to 3 months
Secondary Outcomes (3)
Improvement of asthma control by C-ACT
Up to 3 months
Improvement of asthma control by reduction of bronchodilator
Up to 3 months
Improvement of asthma control by improvement of FEV-1
Up to 3 months
Study Arms (2)
Reuterin D3 drops
ACTIVE COMPARATORLactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
Placebo
PLACEBO COMPARATORThe patients will receive 5 drops/day of placebo for 3 months
Interventions
5 drops/day for 3 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second University of Naples
Naples, Italy, Italy
Related Publications (1)
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.
PMID: 27720582DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
March 18, 2016
First Posted
April 12, 2016
Study Start
April 1, 2014
Primary Completion
February 1, 2015
Study Completion
March 1, 2016
Last Updated
April 12, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share