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

G

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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