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
  Purpose

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


Condition Intervention
Ulcerative Colitis, Crohns Disease
Other: mare's milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • activity indices (CDAI, CAI) [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: July 2000
Study Completion Date: February 2001
Primary Completion Date: February 2001 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

lactose intolerance and pregnancy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940576

Locations
Germany
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, D-07743
Sponsors and Collaborators
University of Jena
Thuringia Ministry of Education and Research
  More Information

No publications provided

Responsible Party: Prof. Dr. G. Jahreis, University of Jena, Dept. of Nutritional Physiology
ClinicalTrials.gov Identifier: NCT00940576     History of Changes
Other Study ID Numbers: LSEP_H08b-00
Study First Received: July 15, 2009
Last Updated: July 15, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
mare's milk, Crohn's disease, ulcerative colitis, clinical study

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014