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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri | Active Comparator | Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day |
|
| Placebo | Placebo Comparator | Rubbed into skin twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical L. reeuteri | Other | Tubes with ointment containing L. reuteri DSM17938 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin appearance modification | 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 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938 | 16 weeks |
| Changes on Quality of life | To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Children's Dermatology Life Quality Index Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pedro Gutierrez-Castrellon, MD, PhD | Contact | +525540003000 | 1246 | pedro.gutierrez@ideas-salud.mx |
| Guadalupe Maldonado-Colin, MSc | Contact | +525540003000 | 1246 | dramaldonado.dermapedia@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Dr. Manuel Gea Gonzalez | Recruiting | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31721162 | Background | 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. | |
| 31441896 | Background |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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.
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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
| 16 weeks |
| Changes on Family Quality of life: Familys Dermatology Life Quality Index Score | To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score. | 16 weeks |
| Frecuency of rescue medications | To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications | 16 weeks |
| Changes on Skin microbiota | To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis. | 12 weeks |
| Yang W, Tu R, Hu Y, He T, Zhang W, Gu L, Liu H. Probiotics supplement for the prevention of eczema in children: Study protocol for a meta-analysis and systematic review. Medicine (Baltimore). 2019 Aug;98(34):e16957. doi: 10.1097/MD.0000000000016957. |
| 31117100 | Background | 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. |
| 30465329 | Background | 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. |
| 29117309 | Background | 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. |
| 29022387 | Background | 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. |
| 26733351 | Background | 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. |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |