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

September 26, 2006 updated by: Groningen Research Institute for Asthma and COPD

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Significant decrease of SCORAD score in treated infants compared to placebo

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groningen Research Institute for Asthma and COPD

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

September 27, 2006

Last Update Submitted That Met QC Criteria

September 26, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METc/99/07/116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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