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

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Crohns Disease
• Interventions: Dietary Supplement: mare´s milk; Other: placebo drink

• Registration Number: NCT00940576
• Lead Sponsor: University of Jena

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-07
• Primary Completion: 2001-02
• Study Completion: 2001-02
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Results First Submitted: 2009-07-17
• Results First Submitted QC: 2015-04-01
• Results First Posted: 2015-04-20
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

lactose intolerance and pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
mare´s milk	placebo drink	oral intake of of 250 ml mare´s milk
mare´s milk	mare´s milk	oral intake of of 250 ml mare´s milk
placebo drink	mare´s milk	oral intake of of 250 ml placebo drink
placebo drink	placebo drink	oral intake of of 250 ml placebo drink

Primary Outcome Measures

Name	Time	Method
Score of Crohn´s Disease and/or Ulcerative Colitis	8 weeks	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

Name	Time	Method
Extra-intestinal Pain	8 weeks	The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).

Trial Locations

Locations (2)

Friedrich Schiller University Jena, Department of Nutritional Physiology; 🇩🇪 Jena, Thuringia, Germany

University of Jena, Institute of Nutrition, Department of Nutritional Physiology; 🇩🇪 Jena, Thuringia, Germany