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
  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
Dietary Supplement: mare´s milk
Other: placebo drink

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:
  • 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.


Secondary Outcome Measures:
  • 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).


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)
Arms Assigned Interventions
Experimental: mare´s milk
oral intake of of 250 ml mare´s milk
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)
Placebo Comparator: placebo drink
oral intake of of 250 ml placebo drink
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)

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
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, Germany, D-07743
Sponsors and Collaborators
University of Jena
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Gerhard Jahreis, Prof. Dr. Professor in Ordinary
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr., University of Jena
ClinicalTrials.gov Identifier: NCT00940576     History of Changes
Other Study ID Numbers: LSEP_H08b-00
Study First Received: July 15, 2009
Results First Received: July 17, 2009
Last Updated: May 5, 2015
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 25, 2015