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

NCT ID: NCT00940576

Last Updated: 2015-05-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2001-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Ulcerative Colitis Crohns Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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mare´s milk

oral intake of of 250 ml mare´s milk

Group Type EXPERIMENTAL

mare´s milk

Intervention Type DIETARY_SUPPLEMENT

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

placebo drink

Intervention Type OTHER

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

placebo drink

oral intake of of 250 ml placebo drink

Group Type PLACEBO_COMPARATOR

mare´s milk

Intervention Type DIETARY_SUPPLEMENT

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

placebo drink

Intervention Type OTHER

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

Interventions

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mare´s milk

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

Intervention Type DIETARY_SUPPLEMENT

placebo drink

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

lactose intolerance and pregnancy
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jahreis

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Jahreis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Professor in Ordinary

Locations

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Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, Germany

Site Status

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

Jena, Thuringia, Germany

Site Status

Countries

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Germany

Other Identifiers

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LSEP_H08b-00

Identifier Type: -

Identifier Source: org_study_id

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