The Effects of Probiotics in Atopic Dermatitis

NCT00378300 | Withdrawn

• 1 other identifier: 06-08-007-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Probiotics; T Regulatory Cells

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Interventions

Oral Probiotics DRUG

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (8)

• 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.

  PMID: 11297958 BACKGROUND

• 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.

  PMID: 11069570 BACKGROUND

• 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.

  PMID: 11122221 BACKGROUND

• 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.

  PMID: 12788576 BACKGROUND

• 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.

  PMID: 12589361 BACKGROUND

• 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.

  PMID: 15863468 BACKGROUND

• 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.

  PMID: 15727582 BACKGROUND

• 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.

  PMID: 15940144 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Tatiana Hernandez

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 19, 2006
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)