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To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Reuterin D3 drops
Placebo
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT), Asthma Exacerbations

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Second University of Naples

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Reuterin D3 drops

Placebo

Arm Description

Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)

The patients will receive 5 drops/day of placebo for 3 months

Outcomes

Primary Outcome Measures

Reduction of allergic bronchial inflammation
Reduction of FeNO values
Reduction of allergic bronchial inflammation
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.

Secondary Outcome Measures

Improvement of asthma control by C-ACT
Improvement in asthma control assessed by: C-ACT (Scores > 19)
Improvement of asthma control by reduction of bronchodilator
Improvement in asthma control assessed by: Reduction use of bronchodilator
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)

Full Information

First Posted
March 18, 2016
Last Updated
April 5, 2016
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT02734446
Brief Title
To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Official Title
Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Bronchial Inflammation, Asthma, Childhood Asthma Control Test (C-ACT), Asthma Exacerbations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reuterin D3 drops
Arm Type
Active Comparator
Arm Description
Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients will receive 5 drops/day of placebo for 3 months
Intervention Type
Drug
Intervention Name(s)
Reuterin D3 drops
Other Intervention Name(s)
Lactobacillus reuteri DSM 17938 + Vit. D3
Intervention Description
5 drops/day for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
5 drops/day for 3 months
Primary Outcome Measure Information:
Title
Reduction of allergic bronchial inflammation
Description
Reduction of FeNO values
Time Frame
Up to 3 months
Title
Reduction of allergic bronchial inflammation
Description
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Improvement of asthma control by C-ACT
Description
Improvement in asthma control assessed by: C-ACT (Scores > 19)
Time Frame
Up to 3 months
Title
Improvement of asthma control by reduction of bronchodilator
Description
Improvement in asthma control assessed by: Reduction use of bronchodilator
Time Frame
Up to 3 months
Title
Improvement of asthma control by improvement of FEV-1
Description
Improvement in asthma control assessed by: Improvement of Forced Expiratory Volume in 1 second (FEV-1)
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Second University of Naples
City
Naples
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
27720582
Citation
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.
Results Reference
derived

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To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children

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