Clinical trial NCT00753805: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: mare's milk
atopic dermatitis
endogenous eczema
SCORAD
Bifidobacteria
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-09-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: SCORAD change
timeFrame: 16 weeks
Secondary outcomes:
measure: Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University of Jena, Institute of Nutrition, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: University of Jena, Dept. of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: