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

April 5, 2016 updated by: Prof. Michele Miraglia del Giudice, University of Campania "Luigi Vanvitelli"

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy
        • Second University of Naples

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reuterin D3 drops
Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
Drug: Reuterin D3 drops
5 drops/day for 3 months
Other Names:
  • Lactobacillus reuteri DSM 17938 + Vit. D3
Placebo Comparator: Placebo
The patients will receive 5 drops/day of placebo for 3 months
Other: Placebo
5 drops/day for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of allergic bronchial inflammation
Time Frame: Up to 3 months
Reduction of FeNO values
Up to 3 months
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.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of asthma control by C-ACT
Time Frame: Up to 3 months

Improvement in asthma control assessed by:

C-ACT (Scores > 19)
Up to 3 months
Improvement of asthma control by reduction of bronchodilator
Time Frame: Up to 3 months

Improvement in asthma control assessed by:

Reduction use of bronchodilator
Up to 3 months
Improvement of asthma control by improvement of FEV-1
Time Frame: Up to 3 months

Improvement in asthma control assessed by:

Improvement of Forced Expiratory Volume in 1 second (FEV-1)
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTN_D3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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