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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Drug: Oral Probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 56
Study Start Date: July 2007
Estimated Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378300

Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Thrasher Research Fund
Investigators
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
  More Information

Publications:

Responsible Party: Michael Land, UCLA Medical Center
ClinicalTrials.gov Identifier: NCT00378300     History of Changes
Other Study ID Numbers: 06-08-007-01
Study First Received: September 18, 2006
Last Updated: June 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Atopic Dermatitis
Probiotics
T Regulatory Cells

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 31, 2014