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Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02945683
Recruitment Status : Unknown
Verified October 2016 by Noos S.r.l..
Recruitment status was:  Recruiting
First Posted : October 26, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Noos S.r.l.

Study Description
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Brief Summary:
The purpose of this study is to evaluate in a randomized, double-blinded, controlled trial, whether a new food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 (Reuterin® D3) may improve the SCORAD in pediatric patients with mild to moderate atopic dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: Reuterin D3 Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
Study Start Date : February 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Reuterin D3
Patients should take 10 drops once a day during meals for 3 months
 Dietary Supplement: Reuterin D3
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
 Dietary Supplement: Placebo
sunflower oil, medium chain triglycerides, silicon dioxide


Outcome Measures
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Primary Outcome Measures :
  1. SCORAD improvement [ Time Frame: 3 months ]
    Improvement of the SCORAD compared to baseline


Secondary Outcome Measures :
  1. Vitamin D levels increase [ Time Frame: 3 months ]
    Increase of the levels of Vit. D compared to baseline

  2. LL-37 levels increase [ Time Frame: 3 months ]
    Increase of the levels of cathelicidin compared to baseline

  3. Changes in the fecal microflora [ Time Frame: 3 months ]
    Changes in the fecal microflora compared to baseline

  4. QoL improvement [ Time Frame: 3 months ]
    Improvement of the child's quality of life


Other Outcome Measures:
  1. Food Frequency Questionnaire [ Time Frame: 3 months ]
    Evaluation of the child's eating habits


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945683


Contacts
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Contact: Attilio Boner, Professor +390458124615 attilio.boner@univr.it

Locations
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Italy
Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Contact: Attilio Boner, Professor    +390458124615    attilio.boner@univr.it   
Sponsors and Collaborators
Noos S.r.l.
Investigators
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Principal Investigator: Attilio Boner, Professor Policlinico G.B. Rossi, Head of the Pediatric Department
More Information
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Responsible Party: Noos S.r.l.
ClinicalTrials.gov Identifier: NCT02945683    
Other Study ID Numbers: ATOPIA_D3
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Noos S.r.l.:
atopic dermatitis, probiotics, vitamin D3, L. reuteri
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases