Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 154 for:    Dermatitis, Atopic, 8

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.


Layout table for study information
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
Drug Information available for: Vitamin D

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location contacts
Contact: Attilio Boner, Professor +390458124615 attilio.boner@univr.it

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Attilio Boner, Professor Policlinico G.B. Rossi, Head of the Pediatric Department

Layout table for additonal information
Responsible Party: Noos S.r.l.
ClinicalTrials.gov Identifier: NCT02945683     History of Changes
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:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents