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

Ulcerative Colitis Clinical Trial

Official title:

Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940576
• Other study ID #: LSEP_H08b-00
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: May 5, 2015
• Start date: July 2000
• Est. completion date: February 2001

Study information

• Verified date: May 2015
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

lactose intolerance and pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohns Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

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)

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Department of Nutritional Physiology	Jena	Thuringia
Germany	University of Jena, Institute of Nutrition, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
University of Jena	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of Crohn´s Disease and/or Ulcerative Colitis	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.	8 weeks	No
Secondary	Extra-intestinal Pain	The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).	8 weeks	No