|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | September 18, 2006 | ||||||||||||||||
| Last Updated Date | June 20, 2008 | ||||||||||||||||
| Start Date ICMJE | July 2007 | ||||||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00378300 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | The Effects of Probiotics in Atopic Dermatitis | ||||||||||||||||
| Official Title ICMJE | 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.
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 ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||||||||||
| Condition ICMJE | Atopic Dermatitis | ||||||||||||||||
| Intervention ICMJE | Drug: Oral Probiotics | ||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * |
|
||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||||||||||
| Estimated Enrollment ICMJE | 56 | ||||||||||||||||
| Estimated Completion Date | June 2008 | ||||||||||||||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Both | ||||||||||||||||
| Ages | 6 Months to 3 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00378300 | ||||||||||||||||
| Responsible Party | Michael Land, UCLA Medical Center | ||||||||||||||||
| Study ID Numbers ICMJE | 06-08-007-01 | ||||||||||||||||
| Study Sponsor ICMJE | University of California, Los Angeles | ||||||||||||||||
| Collaborators ICMJE | Thrasher Research Fund | ||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | University of California, Los Angeles | ||||||||||||||||
| Verification Date | June 2008 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||