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

• ClinicalTrials.gov Identifier: NCT02945683
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Last Update Posted: March 22, 2023
• Sponsor: Noos S.r.l.
• Information provided by (Responsible Party): Noos S.r.l.

Tracking Information

• First Submitted Date: October 24, 2016
• First Posted Date: October 26, 2016
• Last Update Posted Date: March 22, 2023
• Actual Study Start Date: February 2015
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2016)

SCORAD improvement [ Time Frame: 3 months ]

Improvement of the SCORAD compared to baseline

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 24, 2016)

• Vitamin D levels increase [ Time Frame: 3 months ]
  Increase of the levels of Vit. D compared to baseline
• LL-37 levels increase [ Time Frame: 3 months ]
  Increase of the levels of cathelicidin compared to baseline
• Changes in the fecal microflora [ Time Frame: 3 months ]
  Changes in the fecal microflora compared to baseline
• QoL improvement [ Time Frame: 3 months ]
  Improvement of the child's quality of life

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: October 24, 2016)

Food Frequency Questionnaire [ Time Frame: 3 months ]

Evaluation of the child's eating habits

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Effects of Lactobacillus Reuteri Plus Vitamin D3 in Children With Atopic Dermatitis
• Official Title: Randomized Controlled Trial to Evaluate the Beneficial Effects of a Probiotic Food Supplement in Children With Atopic Dermatitis
• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Supportive Care
• Condition: Atopic Dermatitis

Intervention

• 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
• Dietary Supplement: Placebo
  sunflower oil, medium chain triglycerides, silicon dioxide

Study Arms

• Active Comparator: Reuterin D3
  Patients should take 10 drops once a day during meals for 3 months
  Intervention: Dietary Supplement: Reuterin D3
• Placebo Comparator: Placebo
  Patients should take 10 drops once a day during meals for 3 months
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 24, 2016): 88
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2018
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 4 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02945683
• Other Study ID Numbers: ATOPIA_D3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Noos S.r.l.
• Original Responsible Party: Same as current
• Current Study Sponsor: Noos S.r.l.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Attilio Boner, Professor; Policlinico G.B. Rossi, Head of the Pediatric Department

• PRS Account: Noos S.r.l.
• Verification Date: March 2023