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Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases

This study has been completed.
Sponsor:
Collaborator:
Thuringia Ministry of Education and Research
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT00940576
First received: July 15, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 15, 2009
July 15, 2009
July 2000
February 2001   (final data collection date for primary outcome measure)
activity indices (CDAI, CAI) [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
parameters of blood, urine, faeces, and parameters recorded by patients (bristol stool scale, visible blood in faeces, abdominal and extraintestinal disorders) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.

Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.

Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.

Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis, Crohns Disease
Other: 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
17
February 2001
February 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.

Exclusion Criteria:

lactose intolerance and pregnancy

Both
10 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00940576
LSEP_H08b-00
Yes
Prof. Dr. G. Jahreis, University of Jena, Dept. of Nutritional Physiology
University of Jena
Thuringia Ministry of Education and Research
Not Provided
University of Jena
July 2009

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