Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease (NCT01203254) | Clinical Trial Compass
TerminatedPhase 4
Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Stopped: insufficient enrollment
Germany34 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Signed informed consent after adequate explanation of the patient information.
* Male and female patients with CD and 18 to 65 years of age in clinical remission with a Crohns Disease Activity Index (CDAI) score of 150 or less, with symptoms of functional BAM or symptoms of BAM after small bowel resection with a frequency of at least 3 to maximal 15 liquid or soft stools per day.
* Stable medical treatment of CD for a minimal period of 3 months preceding the screening visit, consisting of
* either continuous oral treatment of aminosalicylate, prednisolone (a maximum 10 mg/day), azathioprine, 6-mercaptopurine, or methotrexate
* or supporting periodic treatment\* with TNF-alpha AK (Infliximab, Adalimumab, Certolizumab) (for patients on TNF-alpha, dosing with TNF-alpha should coincide with baseline visit)
* Blood serum CRP value of less or equal then 1 mg/dl (10 mg/l).
* BAM assessed with a blood test on a 7α-hydroxy-4-cholesten-3-on excretion of equal or more than 50 ng/ml
Exclusion criteria:
* Allergy or hypersensitivity to any of the components of cholestagel or placebo as identified from the medical history
* Participation at another clinical trial within a period of 4 weeks before the screening visit
* Presence of any addiction, alcohol abuse or specific disease that would not allow the patient to understand the essence and requirements and potential consequences of the participation to the clinical trial
* Signs suggestive of the patient being…