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

Atopic Dermatitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224432
• Other study ID #: METc/99/07/116
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: September 26, 2006
• Start date: March 2001
• Est. completion date: September 2002

Study information

• Verified date: September 2006
• Source: Groningen Research Institute for Asthma and COPD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Atopic Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Infantile Eczema

Intervention

Drug:
• probiotics: Lactobacillus GG, lactobacillus Rhamnosus

Locations

Country	Name	City	State
Netherlands	Beatrix Children's Hospital, University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Groningen Research Institute for Asthma and COPD	Numico Research Wageningen, the Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant decrease of SCORAD score in treated infants compared to placebo
Secondary	IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells
Secondary	change in fecal TNF-a and a-1-antitrypsin, urinary EDN
Secondary	effect on faecal bacteria after probiotics