Skip to main content
OpenTrials
Completed

NCT Number: NCT00940576

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohns Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich Schiller University Jena, Department of Nutritional Physiology, Jena, Thuringia, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

lactose intolerance and pregnancy

Treatment and study plan

mare´s milk

Dietary Supplement

oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)

Placebo drink

Other

oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Jul 16, 2009
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.