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

May 5, 2015 updated by: Gerhard Jahreis, University of Jena

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

Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Friedrich Schiller University Jena, Department of Nutritional Physiology
      • Jena, Thuringia, Germany, D-07743
        • University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

lactose intolerance and pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mare´s milk
oral intake of of 250 ml mare´s milk
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 Comparator: placebo drink
oral intake of of 250 ml placebo drink
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Crohn´s Disease and/or Ulcerative Colitis
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extra-intestinal Pain
Time Frame: 8 weeks
The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Gerhard Jahreis, Prof. Dr., Professor in Ordinary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2000

Primary Completion (Actual)

February 1, 2001

Study Completion (Actual)

February 1, 2001

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSEP_H08b-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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