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Completed

NCT Number: NCT00224432

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

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.

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Key information

Conditions

Atopic Dermatitis Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infantile Eczema Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 year–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, 9700 RB, Netherlands

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

probiotics: Lactobacillus GG, lactobacillus Rhamnosus

Drug

Primary outcomes

  1. Significant decrease of SCORAD score in treated infants compared to placebo

Secondary outcomes

  1. IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells

  2. change in fecal TNF-α and α-1-antitrypsin, urinary EDN

  3. effect on faecal bacteria after probiotics

Sponsors and collaborators

Lead sponsor

Groningen Research Institute for Asthma and COPD

Other

Collaborators

  • Numico Research Wageningen, the Netherlands

Registry information

Official study 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.

Important dates

Study start
2001
Study completion
2002
First posted
Sep 23, 2005
Registry last updated
Sep 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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