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

Groningen Research Institute for Asthma and COPD

Status

Completed

Conditions

Atopic Dermatitis

Infantile Eczema

Atopic Eczema

Treatments

Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus

Study type

Interventional

Funder types

Other

Identifiers

NCT00224432

METc/99/07/116

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

Under 5 months old

Volunteers

No 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