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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

September 15, 2008
September 15, 2008
August 2004
July 2005   (final data collection date for primary outcome measure)
SCORAD change [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Dietetic Effects of Mare's Milk in Patients With Atopic Dermatitis
Dietetic Effects of Oral Intervention With Mare's Milk on the SCORAD, Faecal Microbiota and Immunological Parameters 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
July 2005
July 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00753805
LSEP H15-04
Yes
Prof. Dr. G. Jahreis, University of Jena, Dept. of Nutritional Physiology
University of Jena
German Federal Ministry of Education and Research
Principal Investigator: Gerhard Jahreis, Prof. Dr. University of Jena, Dept. of Nutritional Physiology
University of Jena
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP