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Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis (PROPAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03863418
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:

Atopic dermatitis (AD) is a multifactorial, chronic inflammatory skin disorder that results in areas of dry, itchy skin. AD affects up to 20% of children in Western societies and represents a prevalent, burdensome, and psychologically important pediatric concern.

It often appears in infancy and may persist into adolescence and adulthood. This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens.

It often appears in infancy and may persist into adolescence and adulthood. This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens.

This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens. This phenomenon may be primarily related to mutations in important barrier proteins, in the same fashion as filaggrin in the atopic skin, or may be secondary, reflecting the intestinal mucosal damage caused by local hypersensitivity reactions to food antigens or to microbial components as in inflammatory bowel disease. Conventional therapy for AD consists of elimination of exacerbating factors, moisturizers to maintain skin hydration, antihistamines to alleviate pruritus, topically applied corticosteroids, or topical calcineurin inhibitors to control inflammation. Severe forms of atopic dermatitis may need systemic corticosteroids, oral cyclosporine, and/or phototherapy.

Probiotics have been suggested as a novel treatment approach for atopic dermatitis. Specific probiotics have been shown to normalize intestinal permeability, to counteract intestinal immune dysfunction and to normalize gut dysbiosis. Hence, their clinical benefit may reside in the control of gut inflammation induced by various intraluminal antigens and enhancement of adaptive and especially innate immune responses.

Indeed, above and beyond balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms. However, there are conflicting evidence on the utility of selected probiotic strains for atopic dermatitis, and major problems are due to dose and viability of strain used, duration of treatment, study population.

The aim of this randomized, double-blind, placebo-controlled study is to evaluate the efficacy of the most studied probiotic in the pediatric allergy field - Lactobacillus rhamnosus GG (LGG) - in children affected by atopic dermatitis.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: Lactobacillus rhamnosus GG Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Probiotic Lactobacillus Rhamnosus GG for Treatment of Atopic Dermatitis in Children
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Lactobacillus rhamnosus GG
Lactobacillus rhamnosus GG (10 billion Colony Forming Units/CAPSULE)
Dietary Supplement: Lactobacillus rhamnosus GG
PROBIOTIC

Placebo Comparator: placebo
maltodextrin
Other: placebo
placebo




Primary Outcome Measures :
  1. Reduction of SCORing Atopic Dermatitis (SCORAD) [ Time Frame: after 12-week treatment ]
    The efficacy of LGG supplementation on clinical course of children in terms of reduction of SCORAD index (score minimum 0 - maximum 60)


Secondary Outcome Measures :
  1. Composition of gut microbiota [ Time Frame: after 12-week treatment ]
    gut microbiota metagenomic in term of total genomic DNA

  2. Composition of gut microbiota metabolomic feature [ Time Frame: after 12-week treatment ]
    Determination of short chain fatty acids

  3. evaluation acquired immunity [ Time Frame: after 12-week treatment ]
    evaluation acquired immunity by determining fecal Immunoglobulin A levels

  4. evaluation of quality of life [ Time Frame: after 12-week treatment ]
    evaluation of Infant Dermatitis Quality of Life Questionnaire (IDQOL) (score minimum 0 - maximum 30)



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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 6-36 months
  • diagnosis of Atopic Dermatitis according to SCORAD index

Exclusion Criteria

  • Age < 6 months
  • age > 36 months,
  • skin infections,
  • ichthyosis,
  • food allergies,
  • other allergic diseases,
  • chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal and/or respiratory tract,
  • administration of prebiotics/ probiotics/symbiotic/systemic immunomodulators during the 4 weeks before enrolment,
  • treatments with topical immunomodulators (Tacrolimus or Pimecrolimus) over the three months prior to enrolment;
  • use of corticosteroids or calcineurin antagonists or phototherapy in the previous 4 weeks,
  • use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
  • investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
  • participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
  • hypersensitivity to components contained in study product.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863418


Locations
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Italy
University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
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Responsible Party: Roberto Berni Canani, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03863418    
Other Study ID Numbers: 400/19
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases