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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT00940576
First received: July 15, 2009
Last updated: May 5, 2015
Last verified: May 2015
Results First Received: July 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Ulcerative Colitis
Crohns Disease
Interventions: Dietary Supplement: mare´s milk
Other: placebo drink

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Oral Intake of Mare´s Milk First, Then Placebo     Oral Intake of Placebo First, Then Mare´s Milk  
STARTED     8     9  
COMPLETED     8     9  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
All Study Participants Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  17  
Age  
[units: participants]
 
<=18 years     15  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  19.0  (8.4)  
Gender  
[units: participants]
 
Female     10  
Male     7  
Region of Enrollment  
[units: participants]
 
Germany     17  



  Outcome Measures
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1.  Primary:   Score of Crohn´s Disease and/or Ulcerative Colitis   [ Time Frame: 8 weeks ]

2.  Secondary:   Extra-intestinal Pain   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gerhard Jahreis, Prof. Dr.
Organization: University of Jena, Institute of Nutrition, Department of Nutritional Physiology Jena, Thuringia, Germany
phone: +(49)3641/949610
e-mail: gerhard.jahreis@uni-jena.de



Responsible Party: Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier: NCT00940576     History of Changes
Other Study ID Numbers: LSEP_H08b-00
Study First Received: July 15, 2009
Results First Received: July 17, 2009
Last Updated: May 5, 2015
Health Authority: Germany: Ethics Commission