Crohns Disease, Ulcerative Colitis
Conditions
Keywords
mare's milk, Crohn's disease, ulcerative colitis, clinical
Brief summary
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTmare´s milk
oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)
OTHERplacebo drink
oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
Sponsors
German Federal Ministry of Education and Research
University of Jena
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
Exclusion criteria
lactose intolerance and pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of Crohn´s Disease and/or Ulcerative Colitis | 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
| Measure | Time frame | Description |
|---|---|---|
| Extra-intestinal Pain | 8 weeks | The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 15 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 19.0 years STANDARD_DEVIATION 8.4 |
| Region of Enrollment Germany | 17 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Study Population | Score of Crohn´s Disease and/or Ulcerative Colitis | Start of placebo | 43 units on a scale | Standard Deviation 16 |
| Entire Study Population | Score of Crohn´s Disease and/or Ulcerative Colitis | Start of mare´s milk | 57 units on a scale | Standard Deviation 22 |
| Entire Study Population | Score of Crohn´s Disease and/or Ulcerative Colitis | End of placebo | 51 units on a scale | Standard Deviation 20 |
| Entire Study Population | Score of Crohn´s Disease and/or Ulcerative Colitis | End of mare´s milk | 54 units on a scale | Standard Deviation 16 |
| Entire Study Population | Score of Crohn´s Disease and/or Ulcerative Colitis | Baseline | 58 units on a scale | Standard Deviation 20 |
| Patients Ulcerative Colitis | Score of Crohn´s Disease and/or Ulcerative Colitis | End of mare´s milk | 2.8 units on a scale | Standard Deviation 3.1 |
| Patients Ulcerative Colitis | Score of Crohn´s Disease and/or Ulcerative Colitis | Baseline | 1.8 units on a scale | Standard Deviation 2.2 |
| Patients Ulcerative Colitis | Score of Crohn´s Disease and/or Ulcerative Colitis | Start of placebo | 1.2 units on a scale | Standard Deviation 1.6 |
| Patients Ulcerative Colitis | Score of Crohn´s Disease and/or Ulcerative Colitis | End of placebo | 1.8 units on a scale | Standard Deviation 2.3 |
| Patients Ulcerative Colitis | Score of Crohn´s Disease and/or Ulcerative Colitis | Start of mare´s milk | 1.7 units on a scale | Standard Deviation 2.4 |
Secondary
Extra-intestinal Pain
The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Entire Study Population | Extra-intestinal Pain | Baseline | 28 Percentage of days with pain | Standard Deviation 14 |
| Entire Study Population | Extra-intestinal Pain | Start of placebo | 37 Percentage of days with pain | Standard Deviation 25 |
| Entire Study Population | Extra-intestinal Pain | End of placebo | 29 Percentage of days with pain | Standard Deviation 15 |
| Entire Study Population | Extra-intestinal Pain | End of mare´s milk | 10 Percentage of days with pain | Standard Deviation 2 |
| Entire Study Population | Extra-intestinal Pain | Start of mare´s milk | 29 Percentage of days with pain | Standard Deviation 15 |