Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
mare's milk
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring mare's milk, atopic dermatitis, endogenous eczema, SCORAD, Bifidobacteria
Eligibility Criteria
Inclusion Criteria:
- A clear and definite diagnosis of AD
- Willingness to use only the recommended drugs
- Competence regarding the daily documentation of skin state and well being.
Exclusion Criteria:
- Therapy with non recommended drugs one month before start of the study
- Active skin infection
- Apparent asthma
- Intolerance against milk
- Long-term therapy with drugs
- Symptomatic heart disease and/or internal disease
- Autoimmune diseases, immune defects, and malignoma
- Alcohol and drug abuse.
Sites / Locations
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Outcomes
Primary Outcome Measures
SCORAD change
Secondary Outcome Measures
Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli)
Full Information
NCT ID
NCT00753805
First Posted
September 15, 2008
Last Updated
September 15, 2008
Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00753805
Brief Title
Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis
Official Title
Dietetic Effects of Oral Intervention With Mare's Milk on the SCORAD, Faecal Microbiota and Immunological Parameters in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was performed to investigate the effects of mare's milk on SCORAD, faecal microbiota and immunological parameters in patients with atopic dermatitis.
Detailed Description
Mare's milk has been used in the treatment of inflammatory illnesses for centuries since it was known to contain antimicrobial, anti-inflammatory and immunomodulatory substances. The aim of this study was to examine whether the consumption of mare's milk by patients with atopic dermatitis (AD) has a beneficial effect.
As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen. Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed for the exclusion of type 1 sensitivity to mare's milk.
The study was designed as a double blind, placebo-controlled crossover trial. Twenty-three patients received 250-ml mare's milk or placebo orally for 16 consecutive weeks. Between the two intervention periods, a four week wash-out period without drinking any test substances was introduced. The intensity of AD was examined using the Severity Scoring of Atopic Dermatitis (SCORAD), which was determined at the start of the study and after 4, 8, 12 and 16 weeks of each intervention period. Blood samples were taken at the start of the study and subsequently after 8 and 16 weeks. Fresh stool samples were taken at the beginning of the study and at the end of each intervention period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
mare's milk, atopic dermatitis, endogenous eczema, SCORAD, Bifidobacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
mare's milk
Intervention Description
The participants received 250 ml mare's milk or placebo daily. The placebo drink was based on a hypoallergenic infant formula.
Primary Outcome Measure Information:
Title
SCORAD change
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clear and definite diagnosis of AD
Willingness to use only the recommended drugs
Competence regarding the daily documentation of skin state and well being.
Exclusion Criteria:
Therapy with non recommended drugs one month before start of the study
Active skin infection
Apparent asthma
Intolerance against milk
Long-term therapy with drugs
Symptomatic heart disease and/or internal disease
Autoimmune diseases, immune defects, and malignoma
Alcohol and drug abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
University of Jena, Dept. of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis
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