Study Results
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Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2007-07-31
2008-06-30
Brief Summary
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Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Interventions
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Oral Probiotics
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
3 Years
ALL
Yes
Sponsors
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Thrasher Research Fund
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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UCLA Medical Center
Principal Investigators
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Michael H Land, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Martin G Martin, MD, MPP
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Robert L Roberts, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Tatiana Hernandez
Role: STUDY_DIRECTOR
University of California, Los Angeles
Locations
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UCLA Medical Center
Los Angeles, California, United States
Countries
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References
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Kalliomaki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. doi: 10.1016/S0140-6736(00)04259-8.
Isolauri E, Arvola T, Sutas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. doi: 10.1046/j.1365-2222.2000.00943.x.
Pessi T, Sutas Y, Hurme M, Isolauri E. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000 Dec;30(12):1804-8. doi: 10.1046/j.1365-2222.2000.00948.x.
Kalliomaki M, Salminen S, Poussa T, Arvilommi H, Isolauri E. Probiotics and prevention of atopic disease: 4-year follow-up of a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1869-71. doi: 10.1016/S0140-6736(03)13490-3.
Rosenfeldt V, Benfeldt E, Nielsen SD, Michaelsen KF, Jeppesen DL, Valerius NH, Paerregaard A. Effect of probiotic Lactobacillus strains in children with atopic dermatitis. J Allergy Clin Immunol. 2003 Feb;111(2):389-95. doi: 10.1067/mai.2003.389.
Weston S, Halbert A, Richmond P, Prescott SL. Effects of probiotics on atopic dermatitis: a randomised controlled trial. Arch Dis Child. 2005 Sep;90(9):892-7. doi: 10.1136/adc.2004.060673. Epub 2005 Apr 29.
Viljanen M, Savilahti E, Haahtela T, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Kuitunen M. Probiotics in the treatment of atopic eczema/dermatitis syndrome in infants: a double-blind placebo-controlled trial. Allergy. 2005 Apr;60(4):494-500. doi: 10.1111/j.1398-9995.2004.00514.x.
Smits HH, Engering A, van der Kleij D, de Jong EC, Schipper K, van Capel TM, Zaat BA, Yazdanbakhsh M, Wierenga EA, van Kooyk Y, Kapsenberg ML. Selective probiotic bacteria induce IL-10-producing regulatory T cells in vitro by modulating dendritic cell function through dendritic cell-specific intercellular adhesion molecule 3-grabbing nonintegrin. J Allergy Clin Immunol. 2005 Jun;115(6):1260-7. doi: 10.1016/j.jaci.2005.03.036.
Other Identifiers
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06-08-007-01
Identifier Type: -
Identifier Source: org_study_id
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