The Effects of Probiotics in Atopic Dermatitis - Tabular View

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The Effects of Probiotics in Atopic Dermatitis

This study has been withdrawn prior to recruitment.

Study NCT00378300. Last updated on June 20, 2008. Information provided by University of California, Los Angeles

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

The Effects of Probiotics in Atopic Dermatitis

Official Title ^†

Probiotics Ameliorate Atopic Dermatitis by Induction of T Regulatory Cells

Brief Summary

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.

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary Outcome Measure ^†

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

Condition ^†

Atopic Dermatitis

Intervention ^†

Drug: Oral Probiotics

MEDLINE PMIDs

11297958, 11069570, 11122221, 12788576, 12589361, 15863468, 15727582, 15940144

Links

Recruitment Information Fields

Recruitment Status ^†

Withdrawn

Enrollment ^†

Start Date ^†

July 2007

Completion Date

June 2008

Eligibility 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

Gender

Both

Ages

6 Months to 3 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00378300

Organization ID

06-08-007-01

Secondary IDs ^††

Study Sponsor ^†

University of California, Los Angeles

Collaborators ^††

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

Information Provided By

University of California, Los Angeles

Verification Date

June 2008

First Received Date ^†

September 18, 2006

Last Updated Date

June 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.