NCT00753805

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
Last Updated

September 17, 2008

Status Verified

June 1, 2008

Enrollment Period

11 months

First QC Date

September 15, 2008

Last Update Submit

September 15, 2008

Conditions

Atopic Dermatitis

Keywords

mare's milkatopic dermatitisendogenous eczemaSCORADBifidobacteria

Outcome Measures

Primary Outcomes (1)

  • SCORAD change

    16 weeks

Secondary Outcomes (1)

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

    16 weeks

Interventions

mare's milkDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jena, Thuringia, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    University of Jena, Dept. of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

August 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

September 17, 2008

Record last verified: 2008-06

Locations

DE(1)