Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients

NCT02585986 | Completed

• 1 other identifier: ATO/PRO1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic conditions.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (2)

• Time of use of topic corticosteroids

  Duration of treatment with topic corticosteroids

  twelve weeks

• Variation in SCORAD score during treatment

  twelve weeks

Secondary Outcomes (3)

• Variation in the Global Clinical Impression (CGI) score during treatment

  twelve weeks

• Exposure to other treatments

  twelve weeks

• side effects due to treatment in two arms of treatment

  twelve weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

daily intake of 1 capsule containing probiotic.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

daily intake of 1 capsule containing placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

daily intake of 1 capsule probiotic

Also known as: Active formulation

Probiotic

Placebo DIETARY_SUPPLEMENT

daily intake of 1 capsule containing placebo

Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• patients that are 4 to 17 years of age.
• 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.

You may not qualify if:

• Pregnancy.
• 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.

Sponsors & Collaborators

• Biopolis S.L.: lead
• Korott, S.L.: collaborator

Study Sites (1)

Centro Dermatologico Estetico de Alicante

Alicante, Alicante, 03014, Spain

Location

Related Publications (23)

• 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.

  PMID: 12694268 BACKGROUND

• Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. doi: 10.1016/S0140-6736(03)12193-9.

  PMID: 12531593 BACKGROUND

• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.

  PMID: 18385500 BACKGROUND

• 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.

  PMID: 12706328 BACKGROUND

• 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.

  PMID: 9068310 BACKGROUND

• 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.

  PMID: 15965431 BACKGROUND

• 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.

  PMID: 16455350 BACKGROUND

• Ridao M. Dermatitis atópica: clínica, diagnóstico diferencial y tratamiento. Pediatr Integral 2004:8:204-10.

  BACKGROUND

• Hanifin JM, Rajka G. Diagnosis features of atopic dermatitis. Acta Derm Venereol 1980;92:44-7.

  BACKGROUND

• 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.

  PMID: 8435513 BACKGROUND

• 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.

  PMID: 9298180 BACKGROUND

• 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.

  PMID: 10871941 BACKGROUND

• 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.

  PMID: 15575941 BACKGROUND

• 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.

  PMID: 16880586 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16815136 BACKGROUND

• 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.

  PMID: 16689857 BACKGROUND

• 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.

  PMID: 17136292 BACKGROUND

• 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.

  PMID: 12399676 BACKGROUND

• 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.

  PMID: 15178928 BACKGROUND

• 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.

  PMID: 18782118 BACKGROUND

• 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.

  PMID: 33921166 DERIVED

• 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.

  PMID: 29117309 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vicente Navarro-López, MD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

• Ana A. Ramirez-Boscá, MD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 26, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

ES (1)