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CompletedNCT00753805Updated Sep 17, 2008

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

An interventional study of mare's milk in Atopic Dermatitis, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2008-09-17.

Sponsored by University of Jena · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 54 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • mare's milk
  • atopic dermatitis
  • endogenous eczema
  • SCORAD
  • Bifidobacteria
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 23 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Interventions

  • Dietary supplementmare's milk

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

06

What researchers measure

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

07

Study locations

1 site
  • University of Jena, Institute of Nutrition, Department of Nutritional Physiology
    Jena, Thuringia, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00753805
Lead sponsor
University of Jena
Collaborators
German Federal Ministry of Education and Research
First posted
Sep 17, 2008
Start date
Aug 2004
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Sep 17, 2008

Study contacts

Gerhard Jahreis, Prof. Dr.
principal investigator · University of Jena, Dept. of Nutritional Physiology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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