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The Effects of Probiotics in Atopic Dermatitis

This study has been withdrawn prior to enrollment.
(Inadequate funding to support this fellow-in-training initiated study.)
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00378300
First received: September 18, 2006
Last updated: June 20, 2008
Last verified: June 2008

September 18, 2006
June 20, 2008
July 2007
June 2008   (final data collection date for primary outcome measure)
  • SCORAD Score change taken at baseline and after 1 month of either probiotic or placebo
  • T Regulatory cell activity change taken at baseline and after 1 month of either probiotic or placebo
Same as current
Complete list of historical versions of study NCT00378300 on ClinicalTrials.gov Archive Site
  • Dermatitis Family Impact Questionnaire change taken at baseline and after 1 month of either probiotic or placebo
  • T Regulatory cell activity when exposed to probiotics in vitro
  • Change in Serum IgE or IgG levels taken at baseline and after 1 month of either probiotic or placebo
Same as current
Not Provided
Not Provided
 
The Effects of Probiotics in Atopic Dermatitis
Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells

The purpose of this study is to study the clinical effects of taking probiotics in patients who have moderate to severe atopic dermatitis. There has been several studies showing improvement in the severity of atopic dermatitis after taking probiotics. The mechanism of this improvement is currently unknown. We propose that probiotics improve atopic dermatitis by stimulating, or increasing, the activity of a special type of cell called the T Regulatory cell--which can suppress the activity of allergic disease.

The central hypothesis of this study is that a subset of commercially available probiotic formulations will ameliorate moderate to severe atopic dermatitis in children by inducing the development of T Regulatory (Treg) cells. We specifically hypothesize that the probiotic mixture that induces Treg activity in vitro, will also improve the severity of atopic dermatitis in a specific patient by inducing Treg activity in vivo.

  1. We will determine whether probiotic mixtures are better able to ameliorate the severity of atopic dermatitis when compared to patients treated with placebo. We will conduct a 4-week randomized, double-blind, placebo controlled clinical trial designed to evaluate the efficacy of probiotics in reducing the clinical severity of atopic dermatitis as assessed by our primary outcome measure, the SCORing Atopic Dermatitis (SCORAD) index. We specifically hypothesize that probiotics will clinically improve the disease.
  2. We will assess whether probiotic mixtures induce the development of T regulatory cells in patients with atopic dermatitis.

A. We will measure the relative levels of Tregs in peripheral blood before and after probiotic or placebo administration in order to assess whether the probiotic mixtures alter Treg development in vivo, and whether these changes correlate with improvement in clinical scores. Primary outcomes will be measurements of gene expression and absolute increases in cell population. We specifically hypothesize that probiotics will increase Treg activity.

B. We will also determine if all patients' Tregs have in vitro responses to probiotics. This data will be used to correlate whether clinical responders in the study also have strong in vitro responses.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Oral Probiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
56
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 6 months to 3 years
  • Physician diagnosis of moderate to severe atopic dermatitis as defined by the Hanifin and Rajka criteria
  • Ability to take enterally commercially available probiotics by powder form added to food or drink
  • Ability to undergo venipuncture or dermal puncture (if less than 1 year old)

Exclusion Criteria:

  • Prior exposure to probiotics
  • Current antibiotic administration
  • Known history of chronic medical condition such as congenital heart disease, liver or kidney disease, or immune deficiency
  • Absence of T regulatory cell induction by probiotic bacteria on initial laboratory assessment
  • Any other condition in which the Investigators involved in the study determine potential subject is unsuitable for the study
Both
6 Months to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00378300
06-08-007-01
No
Michael Land, UCLA Medical Center
University of California, Los Angeles
Thrasher Research Fund
Principal Investigator: Michael H Land, MD University of California, Los Angeles
Principal Investigator: Martin G Martin, MD, MPP University of California, Los Angeles
Principal Investigator: Robert L Roberts, MD, PhD University of California, Los Angeles
Study Director: Tatiana Hernandez University of California, Los Angeles
University of California, Los Angeles
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP