Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Skin appearance modification
Study Overview
Brief Summary
This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product
Detailed Description
AD if a very frequent allergic skin disorders in children. Produce a negative significant impact on quality of life and related costs. Recently the changes of skin microbiota had been related with inadequate evolution of atopic dermatitis.
L. reuteri had been identified with some effect to reduce skin inflammation and help to modulate inflammatory pathways on skin. Investigators expect using topical L. reuteri as adjuvant some improvement on skin appearance due to the mode of action previous referenced additionally to some potential changes on microbiome
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
This is a double-blinded study. All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator. Tubes with interventions has the same exterior appearence. Emollient are similar in consistency and odour
Eligibility Criteria
- Ages
- 1 Year to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children age 1 to 8 years old
- •Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
- •SCORAD Index 15 to 50, inclusive
- •Subjects whose parents or legal representative are willing to sign the informed consent
- •When the child is 8, he/she must also give consent to participate in the study
Exclusion Criteria
- •Use of phototherapy for atopic dermatitis
- •Systemic or topic corticosteroids in tthe 30 days prior to the study
- •Immunosuppressive or cytostatic drugs in the 2 months prior to the study
- •Use of probiotics in the 2 weeks prior to the study
- •Other allergic severe disease (asthma, allergic rhinitis)
- •Systemic antibiotics in the four days prior to the study
- •Fever (temperature> 37.5 °C axillary or equivalent)
- •Pathologies associated with immunodeficiency or cancer processes
- •Dermatological diseases that may hinder the evaluation of atopic dermatitis or require the continued use of topical corticosteroids
- •Subjects for whom any of the studies products are contraindicated according to their technical specifications
- •Subjects who have participated in research studies with any products in the 3 months prior to the trial
Outcomes
Primary Outcomes
Skin appearance modification
Time Frame: 16 weeks
To evaluate the use of a topical emolient containing L. reuteri DSM17938, in terms of its effect on appearance and symptomology in children with mild to moderate atopic dermatitis evaluated by SCORAD test
Secondary Outcomes
- Frequency of adverse events(16 weeks)
- Changes on Quality of life(16 weeks)
- Frecuency of rescue medications(16 weeks)
- Changes on Skin microbiota(12 weeks)
- Changes on Family Quality of life: Familys Dermatology Life Quality Index Score(16 weeks)
Investigators
Pedro Gutierrez Castrellon
Head of Research for Mother-Child
Innovacion y Desarrollo de Estrategias en Salud