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

Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00224432

Enrollment

Registered

2005-09-23

Start date

2001-03-31

Completion date

2002-09-30

Last updated

2006-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Atopic Eczema, Infantile Eczema

Keywords

Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant

Brief summary

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.

Detailed description

* 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

Interventions

DRUGprobiotics: Lactobacillus GG, lactobacillus Rhamnosus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

0 Years to 5 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Significant decrease of SCORAD score in treated infants compared to placebo	—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026