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

Primary Purpose

Atopic Dermatitis, Atopic Eczema, Infantile Eczema

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

probiotics: Lactobacillus GG, lactobacillus Rhamnosus

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant

Eligibility Criteria

0 Years - 5 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beatrix Children's Hospital, University Medical Center Groningen

Outcomes

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

Full Information

NCT ID

NCT00224432

First Posted

September 13, 2005

Last Updated

September 26, 2006

Sponsor

Groningen Research Institute for Asthma and COPD

Collaborators

Numico Research Wageningen, the Netherlands

1. Study Identification

Unique Protocol Identification Number

NCT00224432

Brief Title

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

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

March 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Groningen Research Institute for Asthma and COPD

Collaborators

Numico Research Wageningen, the Netherlands

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis, Atopic Eczema, Infantile Eczema

Keywords

Atopic Dermatitis, SCORAD, probiotics, cytokines, Infant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

45 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

probiotics: Lactobacillus GG, lactobacillus Rhamnosus

Primary Outcome Measure Information:

Title

Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcome Measure Information:

Title

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

Title

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

Title

effect on faecal bacteria after probiotics

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

5 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric J Duiverman, MD, PhD

Organizational Affiliation

Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marianne L Brouwer, MD

Organizational Affiliation

Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beatrix Children's Hospital, University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700 RB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

16839405

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.

Results Reference

result

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

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