The Effects of Probiotics in Atopic Dermatitis
|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|
- 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
- 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
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378300
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|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|