Title

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

    N/A
  • Study Type

    Interventional
  • Intervention/Treatment

    mare milk ...
  • Study Participants

    17
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.
Study Started
Jul 31
2000
Primary Completion
Feb 28
2001
Study Completion
Feb 28
2001
Results Posted
Apr 20
2015
Estimate
Last Update
May 25
2015
Estimate

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 drink Placebo Comparator

oral intake of of 250 ml placebo drink

mare´s milk Experimental

oral intake of of 250 ml mare´s milk

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

lactose intolerance and pregnancy

Summary

Group 1

Group 2

All Events

Event Type Organ System Event Term

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.

Patients Crohn´s Disease

Baseline

58.0
units on a scale (Mean)
Standard Deviation: 20

End of mare´s milk

54.0
units on a scale (Mean)
Standard Deviation: 16

End of placebo

51.0
units on a scale (Mean)
Standard Deviation: 20

Start of mare´s milk

57.0
units on a scale (Mean)
Standard Deviation: 22

Start of placebo

43.0
units on a scale (Mean)
Standard Deviation: 16

Patients Ulcerative Colitis

Baseline

1.8
units on a scale (Mean)
Standard Deviation: 2.2

End of mare´s milk

2.8
units on a scale (Mean)
Standard Deviation: 3.1

End of placebo

1.8
units on a scale (Mean)
Standard Deviation: 2.3

Start of mare´s milk

1.7
units on a scale (Mean)
Standard Deviation: 2.4

Start of placebo

1.2
units on a scale (Mean)
Standard Deviation: 1.6

Extra-intestinal Pain

The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).

Entire Study Population

Baseline

28.0
Percentage of days with pain (Mean)
Standard Deviation: 14

End of mare´s milk

10.0
Percentage of days with pain (Mean)
Standard Deviation: 2

End of placebo

29.0
Percentage of days with pain (Mean)
Standard Deviation: 15

Start of mare´s milk

29.0
Percentage of days with pain (Mean)
Standard Deviation: 15

Start of placebo

37.0
Percentage of days with pain (Mean)
Standard Deviation: 25

Age, Continuous

19.0
years (Mean)
Standard Deviation: 8.4

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Oral Intake of Mare´s Milk First, Then Placebo

Oral Intake of Placebo First, Then Mare´s Milk