Clinical trial NCT00224432: Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Atopic Eczema
Infantile Eczema
Keywords: Atopic Dermatitis
SCORAD
probiotics
cytokines
Infant
Lead sponsor: Groningen Research Institute for Asthma and COPD
Sponsor class: OTHER
Collaborators: name: Numico Research Wageningen, the Netherlands
First posted: 2005-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Significant decrease of SCORAD score in treated infants compared to placebo
Secondary outcomes:
measure: IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
measure: change in fecal TNF-α and α-1-antitrypsin, urinary EDN
measure: effect on faecal bacteria after probiotics
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Beatrix Children's Hospital, University Medical Center Groningen
Study officials:
affiliation: Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
name: Eric J Duiverman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
name: Marianne L Brouwer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906. doi: 10.1111/j.1365-2222.2006.02513.x.