Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
102 participants
INTERVENTIONAL
2020-02-13
2020-10-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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L. reuteri
Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day
Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938
Placebo
Rubbed into skin twice per day
Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938
Interventions
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Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
8 Years
ALL
No
Sponsors
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BioGaia AB
INDUSTRY
Innovacion y Desarrollo de Estrategias en Salud
OTHER
Responsible Party
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Pedro Gutierrez Castrellon
Head of Research for Mother-Child
Locations
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Hospital General Dr. Manuel Gea Gonzalez
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CSUB0174
Identifier Type: -
Identifier Source: org_study_id
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