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

March 16, 2020 updated by: Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico city, Mexico, 14080
        • Recruiting
        • Hospital General Dr. Manuel Gea González
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938
Placebo Comparator: Placebo
Rubbed into skin twice per day
Other: Topical L. reeuteri
Tubes with ointment containing L. reuteri DSM17938

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
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of adverse events
Time Frame: 16 weeks
To evaluate the frequency of adverse events after the use of topical L. reuteri DSM17938
16 weeks
Changes on Quality of life
Time Frame: 16 weeks
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
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.
16 weeks
Frecuency of rescue medications
Time Frame: 16 weeks
To evaluate the improvement on AD control after the use of topical L. reuteri DSM17938 by frequency of rescue medications
16 weeks
Changes on Skin microbiota
Time Frame: 12 weeks
To evaluate the skin microbiome after the use of topical L. reuteri through genomic analysis.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovacion y Desarrollo de Estrategias en Salud

Collaborators

BioGaia AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Anticipated)

May 13, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

February 9, 2020

First Submitted That Met QC Criteria

February 9, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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