Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases
Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.
1 other identifier
interventional
17
1 country
2
Brief Summary
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2000
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 15, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2009
CompletedResults Posted
Study results publicly available
April 20, 2015
CompletedMay 25, 2015
May 1, 2015
7 months
July 15, 2009
July 17, 2009
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of Crohn´s Disease and/or Ulcerative Colitis
score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), \< 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.
8 weeks
Secondary Outcomes (1)
Extra-intestinal Pain
8 weeks
Study Arms (2)
mare´s milk
EXPERIMENTALoral intake of of 250 ml mare´s milk
placebo drink
PLACEBO COMPARATORoral intake of of 250 ml placebo drink
Interventions
oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)
oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
Eligibility Criteria
You may qualify if:
- clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
You may not qualify if:
- lactose intolerance and pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, 07743, Germany
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, D-07743, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerhard Jahreis, Prof. Dr.
- Organization
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology Jena, Thuringia, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Jahreis, Prof. Dr.
Professor in Ordinary
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
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
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
July 15, 2009
First Posted
July 16, 2009
Study Start
July 1, 2000
Primary Completion
February 1, 2001
Study Completion
February 1, 2001
Last Updated
May 25, 2015
Results First Posted
April 20, 2015
Record last verified: 2015-05