Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Dietetic Effects of Oral Intervention With Mare's Milk on the SCORAD, Faecal Microbiota and Immunological Parameters in Patients With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753805
• Other study ID #: LSEP H15-04
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: September 15, 2008
• Start date: August 2004
• Est. completion date: July 2005

Study information

• Verified date: June 2008
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• mare's milk
The participants received 250 ml mare's milk or placebo daily. The placebo drink was based on a hypoallergenic infant formula.

Locations

Country	Name	City	State
Germany	University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD change		16 weeks	Yes
Secondary	Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli)		16 weeks	Yes