search
Back to results

Topical L. Reuteri in Children With Atopic Dermatitis (ADreuteri)

Primary Purpose

Atopic Dermatitis

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Topical L. reeuteri
Sponsored by
Innovacion y Desarrollo de Estrategias en Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atopic Dermatitis

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital General Dr. Manuel Gea GonzalezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

L. reuteri

Placebo

Arm Description

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

Rubbed into skin twice per day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of adverse events
To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
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
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.
Frecuency of rescue medications
To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
Changes on Skin microbiota
To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.

Full Information

First Posted
February 9, 2020
Last Updated
March 16, 2020
Sponsor
Innovacion y Desarrollo de Estrategias en Salud
Collaborators
BioGaia AB
search

1. Study Identification

Unique Protocol Identification Number
NCT04265716
Brief Title
Topical L. Reuteri in Children With Atopic Dermatitis
Acronym
ADreuteri
Official Title
Topical Lactobacillus Reuteri DSM 17938 to Evaluate Safety and Efficacy on Children With Mild or Moderate Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
May 13, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Innovacion y Desarrollo de Estrategias en Salud
Collaborators
BioGaia AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
L. reuteri
Arm Type
Active Comparator
Arm Description
Topical administration of ointment with L. reuteri DSM17938, rubbed into skin twice per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rubbed into skin twice per day
Intervention Type
Other
Intervention Name(s)
Topical L. reeuteri
Intervention Description
Tubes with ointment containing L. reuteri DSM17938
Primary Outcome Measure Information:
Title
Skin appearance modification
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
Time Frame
16 weeks
Title
Changes on Quality of life
Description
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
Time Frame
16 weeks
Title
Changes on Family Quality of life: Familys Dermatology Life Quality Index Score
Description
To evaluate the changes in quality of life after the use of topical L. reuteri DSM17938, evaluated by Familys Dermatology Life Quality Index Score.
Time Frame
16 weeks
Title
Frecuency of rescue medications
Description
To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
Time Frame
16 weeks
Title
Changes on Skin microbiota
Description
To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Gutierrez-Castrellon, MD, PhD
Phone
+525540003000
Ext
1246
Email
pedro.gutierrez@ideas-salud.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Guadalupe Maldonado-Colin, MSc
Phone
+525540003000
Ext
1246
Email
dramaldonado.dermapedia@gmail.com
Facility Information:
Facility Name
Hospital General Dr. Manuel Gea Gonzalez
City
Mexico city
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Gutierrez-Castrellon, MD, PhD
Phone
+525540003000
Ext
1246
Email
inpcochrane@gmail.com
First Name & Middle Initial & Last Name & Degree
Paola Juarez Valdez
Phone
+525540003000
Ext
1246
Email
pao_8816@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31721162
Citation
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.
Results Reference
background
PubMed Identifier
31441896
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.
Results Reference
background
PubMed Identifier
31117100
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.
Results Reference
background
PubMed Identifier
30465329
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.
Results Reference
background
PubMed Identifier
29117309
Citation
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.
Results Reference
background
PubMed Identifier
29022387
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.
Results Reference
background
PubMed Identifier
26733351
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.
Results Reference
background

Learn more about this trial

Topical L. Reuteri in Children With Atopic Dermatitis

We'll reach out to this number within 24 hrs