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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00753805
First received: September 15, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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


Condition Intervention
Atopic Dermatitis
Dietary Supplement: mare's milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietetic Effects of Oral Intervention With Mare's Milk on the SCORAD, Faecal Microbiota and Immunological Parameters in Patients With Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • SCORAD change [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological parameters (ECP, sE-selectin, MDC, IL-16), inflammation biomarker CRP, selected faecal microbiota (bifidobacteria, lactobacilli) [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: August 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753805

Locations
Germany
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. University of Jena, Dept. of Nutritional Physiology
  More Information

No publications provided

Responsible Party: Prof. Dr. G. Jahreis, University of Jena, Dept. of Nutritional Physiology
ClinicalTrials.gov Identifier: NCT00753805     History of Changes
Other Study ID Numbers: LSEP H15-04
Study First Received: September 15, 2008
Last Updated: September 15, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
mare's milk
atopic dermatitis
endogenous eczema
SCORAD
Bifidobacteria

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014