Topical L. Reuteri in Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— ADreuteri  

Official title:

Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265716
• Other study ID #: CSUB0174
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2020
• Source: Innovacion y Desarrollo de Estrategias en Salud
• Contact: Pedro Gutierrez-Castrellon, MD, PhD
• Phone: +525540003000
• Email: pedro.gutierrez[@]ideas-salud.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: October 30, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938

Locations

Country	Name	City	State
Mexico	Hospital General Dr. Manuel Gea Gonzalez	Mexico city

Sponsors (2)

Lead Sponsor	Collaborator
Innovacion y Desarrollo de Estrategias en Salud	BioGaia AB

Country where clinical trial is conducted

Mexico, 

References & 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. 2019 Nov 12. doi: 10.1111/ajd.13186. [Epub ahead of print] Review. — View Citation

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. — View Citation

Navarro-López V, Ramírez-Boscá A, Ramón-Vidal D, Ruzafa-Costas B, Genovés-Martínez S, Chenoll-Cuadros E, Carrión-Gutiérrez M, Horga de la Parte J, Prieto-Merino D, Codoñer-Cortés 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of adverse events	To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938	16 weeks
Secondary	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	16 weeks
Secondary	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
Secondary	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
Secondary	Changes on Skin microbiota	To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.	12 weeks