Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis

Groningen Research Institute for Asthma and COPD45 enrolled

Overview

To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.

* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA * To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA * To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis Atopic Eczema Infantile Eczema

Interventions

probiotics: Lactobacillus GG, lactobacillus RhamnosusDRUG

Eligibility

Sex: ALLMin age: 0 YearsMax age: 5 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis * Suggestive of CMA (one additional symptom) * Scorad index (total) \>20 at study entry * Below 5 months of age * Formula, not breast fed * Written informed consent from the parents Exclusion Criteria: * • Previous or current use of anti-histamines, oral corticosteroids, probiotics * Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks * Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia) * Other GI disease with intestinal inflammation and/or increased intestinal permeability * Skin disorder, not atopic dermatitis * Participation in another clinical study

Locations (1)

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, Netherlands

Outcomes

Primary Outcomes

Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcomes

IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells

change in fecal TNF-α and α-1-antitrypsin, urinary EDN

effect on faecal bacteria after probiotics

Data from ClinicalTrials.gov

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