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

This study has been completed.

Sponsors and Collaborators:	Groningen Research Institute for Asthma and COPD Numico Research Wageningen, the Netherlands
Information provided by:	Groningen Research Institute for Asthma and COPD
ClinicalTrials.gov Identifier:	NCT00224432

Purpose

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.

Condition	Intervention
Atopic Dermatitis Atopic Eczema Infantile Eczema	Drug: probiotics: Lactobacillus GG, lactobacillus Rhamnosus

MedlinePlus related topics: Allergy Eczema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by Groningen Research Institute for Asthma and COPD:

Primary Outcome Measures:

Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcome Measures:

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

Estimated Enrollment:	45
Study Start Date:	March 2001
Estimated Study Completion Date:	September 2002

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

Ages Eligible for Study:	up to 5 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224432

Locations

Netherlands
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

Groningen Research Institute for Asthma and COPD

Numico Research Wageningen, the Netherlands

Investigators

Principal Investigator:	Eric J Duiverman, MD, PhD	Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands
Principal Investigator:	Marianne L Brouwer, MD	Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands

More Information

Publications of Results:

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.

Study ID Numbers:	METc/99/07/116
Study First Received:	September 13, 2005
Last Updated:	September 26, 2006
ClinicalTrials.gov Identifier:	NCT00224432
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Groningen Research Institute for Asthma and COPD:

Atopic Dermatitis
SCORAD
probiotics
cytokines
Infant

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Milk Hypersensitivity

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009