- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04265716
Topical L. Reuteri in Children With Atopic Dermatitis (ADreuteri)
Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
Study Overview
Detailed 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pedro Gutierrez-Castrellon, MD, PhD
- Phone Number: 1246 +525540003000
- Email: pedro.gutierrez@ideas-salud.mx
Study Contact Backup
- Name: Guadalupe Maldonado-Colin, MSc
- Phone Number: 1246 +525540003000
- Email: dramaldonado.dermapedia@gmail.com
Study Locations
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Mexico city, Mexico, 14080
- Recruiting
- Hospital General Dr. Manuel Gea Gonzalez
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Contact:
- Pedro Gutierrez-Castrellon, MD, PhD
- Phone Number: 1246 +525540003000
- Email: inpcochrane@gmail.com
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Contact:
- Paola Juarez Valdez
- Phone Number: 1246 +525540003000
- Email: pao_8816@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: L. reuteri
Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day
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Tubes with ointment containing L. reuteri DSM17938
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Placebo Comparator: Placebo
Rubbed into skin twice per day
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Tubes with ointment containing L. reuteri DSM17938
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin appearance modification
Time Frame: 16 weeks
|
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
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16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of adverse events
Time Frame: 16 weeks
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To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
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16 weeks
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Changes on Quality of life
Time Frame: 16 weeks
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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
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16 weeks
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Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
Time Frame: 16 weeks
|
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score.
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16 weeks
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Frecuency of rescue medications
Time Frame: 16 weeks
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To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
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16 weeks
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Changes on Skin microbiota
Time Frame: 12 weeks
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To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
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12 weeks
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSUB0174
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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