Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients
NCT ID: NCT02585986
Last Updated: 2016-09-13
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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COMPLETED
NA
51 participants
INTERVENTIONAL
2016-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic
daily intake of 1 capsule containing probiotic.
Probiotic
daily intake of 1 capsule probiotic
Placebo
daily intake of 1 capsule containing placebo
Placebo
daily intake of 1 capsule containing placebo
Interventions
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Probiotic
daily intake of 1 capsule probiotic
Placebo
daily intake of 1 capsule containing placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed of atopic dermatitis according to Hanifin and Rajka diagnostic criteria for atopic dermatitis.
* Patients with a SCORAD score ranging from 20 to 40.
* Patients that are actually using, or in which the use of topic corticosteroids to treat the atopic dermatitis flare-ups.
* Patients whose parents or legal representative have signed the informed consent. If the patient is 12 year old or older, the patient has to sign a consent to enter the trial.
Exclusion Criteria
* Breastfeeding.
* Women of childbearing age that do not make a commitment to use any effective contraceptive method.
* Phototherapy treatments to atopic dermatitis
* Systemic corticoid therapy in the last two months.
* Immunosuppressive or cytostatic treatment in the last two months.
* Probiotic treatment in the last two months.
* Systemic antibiotic in the last four months.
* Fever (axillary temperature \> 37ºC or equivalent)
* Severe allergic diseases-
* Immunodeficiency or cancer related processes.
* Other dermatological pathologies that could difficult the atopic dermatitis evaluation, or that require the continued use of topic corticosteroids.
* Any contraindication to any product or drug used during the trial, according to their technical files.
* Participation in any drug clinical trial in the last 3 months.
4 Years
17 Years
ALL
Yes
Sponsors
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Korott, S.L.
INDUSTRY
Biopolis S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Vicente Navarro-López, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica San Antonio de Murcia
Ana A. Ramirez-Boscá, MD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica San Antonio de Murcia
Locations
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Centro Dermatologico Estetico de Alicante
Alicante, Alicante, Spain
Countries
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References
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Ellis C, Luger T, Abeck D, Allen R, Graham-Brown RA, De Prost Y, Eichenfield LF, Ferrandiz C, Giannetti A, Hanifin J, Koo JY, Leung D, Lynde C, Ring J, Ruiz-Maldonado R, Saurat JH; ICCAD II Faculty. International Consensus Conference on Atopic Dermatitis II (ICCAD II): clinical update and current treatment strategies. Br J Dermatol. 2003 May;148 Suppl 63:3-10. doi: 10.1046/j.1365-2133.148.s63.1.x. No abstract available.
Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. doi: 10.1016/S0140-6736(03)12193-9.
Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
Levy RM, Gelfand JM, Yan AC. The epidemiology of atopic dermatitis. Clin Dermatol. 2003 Mar-Apr;21(2):109-15. doi: 10.1016/s0738-081x(02)00360-7. No abstract available.
Su JC, Kemp AS, Varigos GA, Nolan TM. Atopic eczema: its impact on the family and financial cost. Arch Dis Child. 1997 Feb;76(2):159-62. doi: 10.1136/adc.76.2.159.
Simpson EL, Hanifin JM. Atopic dermatitis. J Am Acad Dermatol. 2005 Jul;53(1):115-28. doi: 10.1016/j.jaad.2005.01.130. No abstract available.
Boguniewicz M, Leung DY. 10. Atopic dermatitis. J Allergy Clin Immunol. 2006 Feb;117(2 Suppl Mini-Primer):S475-80. doi: 10.1016/j.jaci.2005.10.018.
Ridao M. Dermatitis atópica: clínica, diagnóstico diferencial y tratamiento. Pediatr Integral 2004:8:204-10.
Hanifin JM, Rajka G. Diagnosis features of atopic dermatitis. Acta Derm Venereol 1980;92:44-7.
Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology. 1993;186(1):23-31. doi: 10.1159/000247298.
Sprikkelman AB, Tupker RA, Burgerhof H, Schouten JP, Brand PL, Heymans HS, van Aalderen WM. Severity scoring of atopic dermatitis: a comparison of three scoring systems. Allergy. 1997 Sep;52(9):944-9. doi: 10.1111/j.1398-9995.1997.tb01255.x.
Charman C, Williams H. Outcome measures of disease severity in atopic eczema. Arch Dermatol. 2000 Jun;136(6):763-9. doi: 10.1001/archderm.136.6.763.
Pucci N, Novembre E, Cammarata MG, Bernardini R, Monaco MG, Calogero C, Vierucci A. Scoring atopic dermatitis in infants and young children: distinctive features of the SCORAD index. Allergy. 2005 Jan;60(1):113-6. doi: 10.1111/j.1398-9995.2004.00622.x.
Bhor U, Pande S. Scoring systems in dermatology. Indian J Dermatol Venereol Leprol. 2006 Jul-Aug;72(4):315-21. doi: 10.4103/0378-6323.26722. No abstract available.
National Institute for health and clinical excellence. Atopic eczema in children. Management of atopic eczema in children from birth up to the age of 12 years. NICE clinical guideline 57. Dec 2007.
Boguniewicz M, Schmid-Grendelmeier P, Leung DY. Atopic dermatitis. J Allergy Clin Immunol. 2006 Jul;118(1):40-3. doi: 10.1016/j.jaci.2006.04.044. Epub 2006 Jun 6. No abstract available.
Schoepe S, Schacke H, May E, Asadullah K. Glucocorticoid therapy-induced skin atrophy. Exp Dermatol. 2006 Jun;15(6):406-20. doi: 10.1111/j.0906-6705.2006.00435.x.
Castro AP. Calcineurin inhibitors in the treatment of allergic dermatitis. J Pediatr (Rio J). 2006 Nov;82(5 Suppl):S166-72. doi: 10.2223/JPED.1557.
Meurer M, Folster-Holst R, Wozel G, Weidinger G, Junger M, Brautigam M; CASM-DE-01 study group. Pimecrolimus cream in the long-term management of atopic dermatitis in adults: a six-month study. Dermatology. 2002;205(3):271-7. doi: 10.1159/000065863.
Meurer M, Fartasch M, Albrecht G, Vogt T, Worm M, Ruzicka T, Altmeyer PJ, Schneider D, Weidinger G, Braeutigam M; CASM-DE-01 Study Group. Long-term efficacy and safety of pimecrolimus cream 1% in adults with moderate atopic dermatitis. Dermatology. 2004;208(4):365-72. doi: 10.1159/000078462.
de Benedictis FM, de Benedictis D, Canonica GW. New oral H1 antihistamines in children: facts and unmeet needs. Allergy. 2008 Oct;63(10):1395-404. doi: 10.1111/j.1398-9995.2008.01771.x.
Climent E, Martinez-Blanch JF, Llobregat L, Ruzafa-Costas B, Carrion-Gutierrez MA, Ramirez-Bosca A, Prieto-Merino D, Genoves S, Codoner FM, Ramon D, Chenoll E, Navarro-Lopez V. Changes in Gut Microbiota Correlates with Response to Treatment with Probiotics in Patients with Atopic Dermatitis. A Post Hoc Analysis of a Clinical Trial. Microorganisms. 2021 Apr 15;9(4):854. doi: 10.3390/microorganisms9040854.
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.
Other Identifiers
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ATO/PRO1
Identifier Type: -
Identifier Source: org_study_id
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