- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02945683
Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent evidence suggests that childhood allergy development can be linked to an imbalance of the intestinal microbiota. The probiotic bacteria, which contribute to the balance of the intestinal microflora, may play a key role in the modulation of the immune response, looking as a potential resource in the prevention or treatment of allergic disorders.
In this study the investigators will recruit pediatric patients with atopic dermatitis of mild-to-moderate degree, for which the standard treatment consists in using an emollient cream and topical steroids in case of exacerbation.
The investigators assume that participants can receive significant benefits from the addition to their standard treatment of a food supplement containing L. reuteri DSM 17938 and vitamin D3, which, thanks to their beneficial effects on intestinal microbiota and on modulation of the immune response, may compensate for the inadequate capacity of these patients to produce antimicrobial peptides in response to cutaneous aggressions, improving, therefore, the severity of the disease.
88 children of both sexes, between 1 and 4 years old, with a SCORAD of 25-50 will be selected as a part of routine outpatient visits at the Pediatric Allergy Department of the University Hospital of Verona.
The study product (active or placebo) will be administered for 3 months, with a follow-up period of further 3 months. From all participants, at time 0 and after 3 months, blood and stool samples will be collected for the analysis of vitamin D and cathelicidin levels and for the analysis of microflora respectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Attilio Boner, Professor
- Phone Number: +390458124615
- Email: attilio.boner@univr.it
Study Locations
-
-
-
Verona, Italy, 37134
- Policlinico G.B. Rossi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of atopic dermatitis of mild to moderate grade (SCORAD 25-50)
- signature of the informed consent from both parents or a legal representative
Exclusion Criteria:
- presence of autoimmune diseases, immunodeficiency, inflammatory bowel diseases, cystic fibrosis, metabolic diseases
- use of immunosuppressive drugs and/or systemic corticosteroids in the previous 2 months
- use of antibiotics in the last 4 weeks
- use of probiotics and/or prebiotics in the last 2 weeks
- use of vitamin D in the last 4 weeks
- participation in other clinical trials
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reuterin D3
Patients should take 10 drops once a day during meals for 3 months
|
Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide
|
Placebo Comparator: Placebo
Patients should take 10 drops once a day during meals for 3 months
|
sunflower oil, medium chain triglycerides, silicon dioxide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SCORAD improvement
Time Frame: 3 months
|
Improvement of the SCORAD compared to baseline
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vitamin D levels increase
Time Frame: 3 months
|
Increase of the levels of Vit.
D compared to baseline
|
3 months
|
LL-37 levels increase
Time Frame: 3 months
|
Increase of the levels of cathelicidin compared to baseline
|
3 months
|
Changes in the fecal microflora
Time Frame: 3 months
|
Changes in the fecal microflora compared to baseline
|
3 months
|
QoL improvement
Time Frame: 3 months
|
Improvement of the child's quality of life
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Frequency Questionnaire
Time Frame: 3 months
|
Evaluation of the child's eating habits
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Attilio Boner, Professor, Policlinico G.B. Rossi, Head of the Pediatric Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATOPIA_D3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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