Probiotic Lactobacillus Rhamnosus GG for Pediatric Atopic Dermatitis

NCT03863418 | Unknown

• 1 other identifier: 400/19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Reduction of SCORing Atopic Dermatitis (SCORAD)

  The efficacy of LGG supplementation on clinical course of children in terms of reduction of SCORAD index (score minimum 0 - maximum 60)

  after 12-week treatment

Secondary Outcomes (4)

• Composition of gut microbiota

  after 12-week treatment

• Composition of gut microbiota metabolomic feature

  after 12-week treatment

• evaluation acquired immunity

  after 12-week treatment

• evaluation of quality of life

  after 12-week treatment

Study Arms (2)

Lactobacillus rhamnosus GG

EXPERIMENTAL

Lactobacillus rhamnosus GG (10 billion Colony Forming Units/CAPSULE)

Dietary Supplement: Lactobacillus rhamnosus GG

placebo

PLACEBO COMPARATOR

maltodextrin

Other: placebo

Interventions

Lactobacillus rhamnosus GG DIETARY_SUPPLEMENT

PROBIOTIC

Lactobacillus rhamnosus GG

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 36003050 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 5, 2019
• Study Start: May 15, 2019
• Primary Completion: May 15, 2020
• Study Completion: December 31, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

IT (1)