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

• ClinicalTrials.gov Identifier: NCT00940576
• Recruitment Status: Completed
• First Posted: July 16, 2009
• Results First Posted: April 20, 2015
• Last Update Posted: May 25, 2015
• Sponsor: University of Jena
• Collaborator: German Federal Ministry of Education and Research
• Information provided by (Responsible Party): Gerhard Jahreis, University of Jena

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Ulcerative Colitis; Crohns Disease	Dietary Supplement: mare´s milk; Other: placebo drink	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, 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.
• Study Start Date: July 2000
• Actual Primary Completion Date: February 2001
• Actual Study Completion Date: February 2001

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. Score of Crohn´s Disease and/or Ulcerative Colitis [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Gerhard Jahreis, Prof. Dr., University of Jena
• ClinicalTrials.gov Identifier: NCT00940576
• Other Study ID Numbers: LSEP_H08b-00
• First Posted: July 16, 2009
• Results First Posted: April 20, 2015
• Last Update Posted: May 25, 2015
• Last Verified: May 2015

Keywords provided by Gerhard Jahreis, University of Jena:

mare's milk, Crohn's disease, ulcerative colitis, clinical

Additional relevant MeSH terms:

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