Clinical trial NCT04265716: Topical L. Reuteri in Children With Atopic Dermatitis
Official title: Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Innovacion y Desarrollo de Estrategias en Salud
Sponsor class: OTHER
Collaborators: name: BioGaia AB
First posted: 2020-02-12
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled trial, 2 parallel arms. Children with mild or moderate atopic dermatitis will be randomly selected at the Pediatric Dermatologic Clinic-Hospital General GEA-Mexico if they fulfill selectioncriteria.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Skin appearance modification
timeFrame: 16 weeks
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 16 weeks
measure: Changes on Quality of life
timeFrame: 16 weeks
measure: Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
timeFrame: 16 weeks
measure: Frecuency of rescue medications
timeFrame: 16 weeks
measure: Changes on Skin microbiota
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General Dr. Manuel Gea Gonzalez
Study officials:
References:
citation: Amalia N, Orchard D, Francis KL, King E. Systematic review and meta-analysis on the use of probiotic supplementation in pregnant mother, breastfeeding mother and infant for the prevention of atopic dermatitis in children. Australas J Dermatol. 2020 May;61(2):e158-e173. doi: 10.1111/ajd.13186. Epub 2019 Nov 12.
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citation: Yan DC, Hung CH, Sy LB, Lue KH, Shih IH, Yang CY, Chen LC, Sun HL, Lee MS, Chambard J, Tanguy J, Hughes-Formella B, Nutten S, Blanchard C. A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Oral Administration of a Heat-Treated Lactobacillus paracasei Supplement in Infants with Atopic Dermatitis Receiving Topical Corticosteroid Therapy. Skin Pharmacol Physiol. 2019;32(4):201-211. doi: 10.1159/000499436. Epub 2019 May 22.
citation: Li L, Han Z, Niu X, Zhang G, Jia Y, Zhang S, He C. Probiotic Supplementation for Prevention of Atopic Dermatitis in Infants and Children: A Systematic Review and Meta-analysis. Am J Clin Dermatol. 2019 Jun;20(3):367-377. doi: 10.1007/s40257-018-0404-3.
citation: Navarro-Lopez V, Ramirez-Bosca A, Ramon-Vidal D, Ruzafa-Costas B, Genoves-Martinez S, Chenoll-Cuadros E, Carrion-Gutierrez M, Horga de la Parte J, Prieto-Merino D, Codoner-Cortes FM. Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Jan 1;154(1):37-43. doi: 10.1001/jamadermatol.2017.3647.
citation: Prakoeswa CRS, Herwanto N, Prameswari R, Astari L, Sawitri S, Hidayati AN, Indramaya DM, Kusumowidagdo ER, Surono IS. Lactobacillus plantarum IS-10506 supplementation reduced SCORAD in children with atopic dermatitis. Benef Microbes. 2017 Oct 13;8(5):833-840. doi: 10.3920/BM2017.0011. Epub 2017 Oct 12.
citation: Wu YJ, Wu WF, Hung CW, Ku MS, Liao PF, Sun HL, Lu KH, Sheu JN, Lue KH. Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study. J Microbiol Immunol Infect. 2017 Oct;50(5):684-692. doi: 10.1016/j.jmii.2015.10.003. Epub 2015 Nov 27.