Skip to main content
OpenTrials
Completed

NCT Number: NCT00753805

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

The study was performed to investigate the effects of mare's milk on SCORAD, faecal microbiota and immunological parameters in patients with atopic dermatitis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mare's milk

Dietary Supplement

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

Primary outcomes

  1. SCORAD change

    Time frame: 16 weeks

Secondary outcomes

  1. Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli)

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 17, 2008
Registry last updated
Sep 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.