Trial Outcomes & Findings for Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases (NCT NCT00940576)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

8 weeks

Results posted on

2015-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=17 Participants Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
Age, Categorical <=18 years	15 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	19.0 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Germany	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Entire Study Population n=8 Participants oral intake of 250 ml mare´s milk or placebo drink daily	Patients Ulcerative Colitis n=9 Participants
Score of Crohn´s Disease and/or Ulcerative Colitis Baseline	58 units on a scale Standard Deviation 20	1.8 units on a scale Standard Deviation 2.2
Score of Crohn´s Disease and/or Ulcerative Colitis Start of placebo	43 units on a scale Standard Deviation 16	1.2 units on a scale Standard Deviation 1.6
Score of Crohn´s Disease and/or Ulcerative Colitis End of placebo	51 units on a scale Standard Deviation 20	1.8 units on a scale Standard Deviation 2.3
Score of Crohn´s Disease and/or Ulcerative Colitis Start of mare´s milk	57 units on a scale Standard Deviation 22	1.7 units on a scale Standard Deviation 2.4
Score of Crohn´s Disease and/or Ulcerative Colitis End of mare´s milk	54 units on a scale Standard Deviation 16	2.8 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Outcome measures
Measure	Entire Study Population n=17 Participants oral intake of 250 ml mare´s milk or placebo drink daily	Patients Ulcerative Colitis
Extra-intestinal Pain Baseline	28 Percentage of days with pain Standard Deviation 14	—
Extra-intestinal Pain Start of placebo	37 Percentage of days with pain Standard Deviation 25	—
Extra-intestinal Pain End of placebo	29 Percentage of days with pain Standard Deviation 15	—
Extra-intestinal Pain Start of mare´s milk	29 Percentage of days with pain Standard Deviation 15	—
Extra-intestinal Pain End of mare´s milk	10 Percentage of days with pain Standard Deviation 2	—

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerhard Jahreis, Prof. Dr.

University of Jena, Institute of Nutrition, Department of Nutritional Physiology Jena, Thuringia, Germany

Phone: +(49)3641/949610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place