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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mare´s milk | Experimental | oral intake of of 250 ml mare´s milk |
|
| placebo drink | Placebo Comparator | oral intake of of 250 ml placebo drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| 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 |
| 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 |
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Inclusion Criteria:
clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
Exclusion Criteria:
lactose intolerance and pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Jahreis, Prof. Dr. | Professor in Ordinary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich Schiller University Jena, Department of Nutritional Physiology | Jena | Thuringia | 07743 | Germany | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Intake of Mare´s Milk First, Then Placebo | Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo |
| FG001 | Oral Intake of Placebo First, Then Mare´s Milk | Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Extra-intestinal Pain | The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP). | Posted | Mean | Standard Deviation | Percentage of days with pain | 8 weeks |
|
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The period in which adverse event data were collected were 3 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | oral intake of 250 ml mare's milk daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerhard Jahreis, Prof. Dr. | University of Jena, Institute of Nutrition, Department of Nutritional Physiology Jena, Thuringia, Germany | +(49)3641/949610 | gerhard.jahreis@uni-jena.de |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| placebo drink | Other | oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design) |
|
| University of Jena, Institute of Nutrition, Department of Nutritional Physiology |
| Jena |
| Thuringia |
| D-07743 |
| Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Group 2 | oral intake of 250 ml placebo daily | 0 | 17 | 0 | 17 |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| End of placebo |
|
| Start of mare´s milk |
|
| End of mare´s milk |
|