Clinical trial NCT03863418: Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis
Official title: The Use of Probiotic Lactobacillus Rhamnosus GG for Treatment of Atopic Dermatitis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Reduction of SCORing Atopic Dermatitis (SCORAD)
timeFrame: after 12-week treatment
Secondary outcomes:
measure: Composition of gut microbiota
timeFrame: after 12-week treatment
measure: Composition of gut microbiota metabolomic feature
timeFrame: after 12-week treatment
measure: evaluation acquired immunity
timeFrame: after 12-week treatment
measure: evaluation of quality of life
timeFrame: after 12-week treatment
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
citation: Carucci L, Nocerino R, Paparo L, De Filippis F, Coppola S, Giglio V, Cozzolino T, Valentino V, Sequino G, Bedogni G, Russo R, Ercolini D, Berni Canani R. Therapeutic effects elicited by the probiotic Lacticaseibacillus rhamnosus GG in children with atopic dermatitis. The results of the ProPAD trial. Pediatr Allergy Immunol. 2022 Aug;33(8):e13836. doi: 10.1111/pai.13836.