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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014