Clinical Trial: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Brief Summary: The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.
Detailed Summary:
Sponsor: Florian Beigel
Current Primary Outcome: Reduction of fluid stool > 30 % [ Time Frame: 4 weeks after baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Improvement of Stool Consistency [ Time Frame: 4 weeks after baseline ]Proportion of patients on cholestagel compared to placebo that reaches improvement of stool consistency on the Bristol stool chart of at least one point.
- Improvement of Quality of Life. [ Time Frame: 4 weeks after baseline ]Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.
- Change of median liquid or soft stool frequency/per day. [ Time Frame: 4 weeks after baseline ]
Original Secondary Outcome: Same as current
Information By: Klinikum der Universitaet Muenchen, Grosshadern
Dates:
Date Received: September 15, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013
