NCT02945683

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

October 24, 2016

Last Update Submit

March 21, 2023

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, probiotics, vitamin D3, L. reuteri

Outcome Measures

Primary Outcomes (1)

  • SCORAD improvement

    Improvement of the SCORAD compared to baseline

    3 months

Secondary Outcomes (4)

  • Vitamin D levels increase

    3 months

  • LL-37 levels increase

    3 months

  • Changes in the fecal microflora

    3 months

  • QoL improvement

    3 months

Other Outcomes (1)

  • Food Frequency Questionnaire

    3 months

Study Arms (2)

Reuterin D3

ACTIVE COMPARATOR

Patients should take 10 drops once a day during meals for 3 months

Dietary Supplement: Reuterin D3

Placebo

PLACEBO COMPARATOR

Patients should take 10 drops once a day during meals for 3 months

Dietary Supplement: Placebo

Interventions

Reuterin D3DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide

Reuterin D3
PlaceboDIETARY_SUPPLEMENT

sunflower oil, medium chain triglycerides, silicon dioxide

Placebo

Eligibility Criteria

Age1 Year - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of atopic dermatitis of mild to moderate grade (SCORAD 25-50)
  • signature of the informed consent from both parents or a legal representative

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico G.B. Rossi

Verona, 37134, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Attilio Boner, Professor

    Policlinico G.B. Rossi, Head of the Pediatric Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

February 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2018

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)