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

Not Applicable

Completed

• Conditions: Atopic Dermatitis; Atopic Eczema; Infantile Eczema

• Registration Number: NCT00224432
• Lead Sponsor: Groningen Research Institute for Asthma and COPD

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

Study Timeline

• Study Start: 2001-03
• Study Completion: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-23
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-26
• Last Update Posted: 2006-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beatrix Children's Hospital, University Medical Center Groningen; 🇳🇱 Groningen, Netherlands