Effect of Probiotics in the Atopic Dermatitis
Primary Purpose
Atopic Dermatitis, Probiotics
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
probiotic ® pur
Sponsored by
About this trial
This is an interventional prevention trial for Atopic Dermatitis, Probiotics focused on measuring Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
Eligibility Criteria
Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -
Exclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
No Intervention
Arm Label
Probiotics
skim milk powder, dextrose
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01224132
First Posted
October 18, 2010
Last Updated
October 18, 2010
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT01224132
Brief Title
Effect of Probiotics in the Atopic Dermatitis
Official Title
Effect of Probiotics in the Treatment of Children With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
Detailed Description
Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Probiotics
Keywords
Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
No Intervention
Arm Title
skim milk powder, dextrose
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
probiotic ® pur
Intervention Description
daily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -
Exclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.
-
12. IPD Sharing Statement
Learn more about this trial
Effect of Probiotics in the Atopic Dermatitis
We'll reach out to this number within 24 hrs