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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT00940576
First received: July 15, 2009
Last updated: May 5, 2015
Last verified: May 2015

July 15, 2009
May 5, 2015
July 2000
February 2001   (final data collection date for primary outcome measure)
Score of Crohn´s Disease and/or Ulcerative Colitis [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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.
activity indices (CDAI, CAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00940576 on ClinicalTrials.gov Archive Site
Extra-intestinal Pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).
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 ]
Not Provided
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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
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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
  • Dietary Supplement: mare´s milk
    oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)
  • Other: placebo drink
    oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
  • Experimental: mare´s milk
    oral intake of of 250 ml mare´s milk
    Interventions:
    • Dietary Supplement: mare´s milk
    • Other: placebo drink
  • Placebo Comparator: placebo drink
    oral intake of of 250 ml placebo drink
    Interventions:
    • Dietary Supplement: mare´s milk
    • Other: placebo drink
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   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00940576
LSEP_H08b-00
Yes
Not Provided
Not Provided
Gerhard Jahreis, University of Jena
University of Jena
German Federal Ministry of Education and Research
Principal Investigator: Gerhard Jahreis, Prof. Dr. Professor in Ordinary
University of Jena
May 2015

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