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

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

Detailed Description
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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.

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

Conditions
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Ulcerative Colitis, Crohns Disease

Intervention / Treatment
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* Dietary Supplement: mare´s milk
* Other: placebo drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clear and definite diagnosis of ulcerative colitis and Crohn's disease resp. Exclusion Criteria: lactose intolerance and pregnancy

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mare´s milk<br>oral intake of of 250 ml mare´s milk | Dietary Supplement: mare´s milk<br>* oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)<br>Other: placebo drink<br>* oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)<br>|
| Placebo Comparator: placebo drink<br>oral intake of of 250 ml placebo drink | Dietary Supplement: mare´s milk<br>* oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)<br>Other: placebo drink<br>* oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mare's milk, Crohn's disease, ulcerative colitis, clinical