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

Primary Purpose

Ulcerative Colitis, Crohns Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

mare´s milk

placebo drink

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring mare's milk, Crohn's disease, ulcerative colitis, clinical

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

lactose intolerance and pregnancy

Sites / Locations

Friedrich Schiller University Jena, Department of Nutritional Physiology
University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mare´s milk

placebo drink

Arm Description

oral intake of of 250 ml mare´s milk

oral intake of of 250 ml placebo drink

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Extra-intestinal Pain

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

Full Information

NCT ID

NCT00940576

First Posted

July 15, 2009

Last Updated

May 5, 2015

Sponsor

University of Jena

Collaborators

German Federal Ministry of Education and Research

1. Study Identification

Unique Protocol Identification Number

NCT00940576

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

July 2000 (undefined)

Primary Completion Date

February 2001 (Actual)

Study Completion Date

February 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Jena

Collaborators

German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Crohns Disease

Keywords

mare's milk, Crohn's disease, ulcerative colitis, clinical

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mare´s milk

Arm Type

Experimental

Arm Description

oral intake of of 250 ml mare´s milk

Arm Title

placebo drink

Arm Type

Placebo Comparator

Arm Description

oral intake of of 250 ml placebo drink

Intervention Type

Dietary Supplement

Intervention Name(s)

mare´s milk

Intervention Description

oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)

Intervention Type

Other

Intervention Name(s)

placebo drink

Intervention Description

oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)

Primary Outcome Measure Information:

Title

Score of Crohn´s Disease and/or Ulcerative Colitis

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Extra-intestinal Pain

Description

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

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Jahreis, Prof. Dr.

Organizational Affiliation

Professor in Ordinary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friedrich Schiller University Jena, Department of Nutritional Physiology

City

Jena

State/Province

Thuringia

ZIP/Postal Code

07743

Country

Germany

Facility Name

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

City

Jena

State/Province

Thuringia

ZIP/Postal Code

D-07743

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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