Topical L. Reuteri in Children With Atopic Dermatitis

NCT04265716 | Unknown

• 1 other identifier: CSUB0174
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Frequency of adverse events

  16 weeks

• Changes on Quality of life

  16 weeks

• Changes on Family Quality of life: Familys Dermatology Life Quality Index Score

  16 weeks

• Frecuency of rescue medications

  16 weeks

• Changes on Skin microbiota

  12 weeks

Study Arms (2)

L. reuteri

ACTIVE COMPARATOR

Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day

Other: Topical L. reeuteri

Placebo

PLACEBO COMPARATOR

Rubbed into skin twice per day

Other: Topical L. reeuteri

Interventions

Topical L. reeuteri OTHER

Tubes with ointment containing L. reuteri DSM17938

L. reuteri; Placebo

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovacion y Desarrollo de Estrategias en Salud: lead
• BioGaia AB: collaborator

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, 14080, Mexico

RECRUITING

Related Publications (7)

• 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.

  PMID: 31721162 BACKGROUND

• 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.

  PMID: 31441896 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.

  PMID: 31117100 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.

  PMID: 30465329 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.

  PMID: 29117309 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.

  PMID: 29022387 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.

  PMID: 26733351 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

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

Central Study Contacts

Pedro Gutierrez-Castrellon, MD, PhD

CONTACT

+525540003000; pedro.gutierrez@ideas-salud.mx

Guadalupe Maldonado-Colin, MSc

CONTACT

+525540003000; dramaldonado.dermapedia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research for Mother-Child

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 12, 2020
• Study Start: February 13, 2020
• Primary Completion: May 13, 2020
• Study Completion: October 30, 2020
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)