The Effects of Probiotics in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT00378300|
Recruitment Status : Withdrawn (Inadequate funding to support this fellow-in-training initiated study.)
First Posted : September 19, 2006
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: Oral Probiotics||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2008|
|Estimated Study Completion Date :||June 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|