Comparing the effect of Liraglutide on bile acid malabsorption, with colesevelam
The overall objective of the present study is to provide proof of concept that treatment with the GLP-1 receptor agonist liraglutide is efficacious (as assessed by symptom relief, i.e. response to treatment) and safe (as assessed by adverse effects) in the management of BAM and that it improves bile acid reabsorption (as assessed by SeHCAT) in these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
52
Liraglutide as injections.
3 x 625 miligram 2 times a day.
Gentofte Hospital
Hellerup, Regionh, Denmark
Change in stool fequency
Contestants will use a questionaire, which will be filled out three times during the 7 weeks periode
Time frame: 7 weeks
Total symptoms score, quality of life scores, and biomarker.
Total symptoms score, quality of life scores, and biomarker values will be analysed using a constrained linear mixed model with inherent baseline adjustment and with an unstructured covariance pattern. Changes since baseline within and between groups will be reported with 95% confidence intervals.
Time frame: 7 weeks
Change in SeHCAT
Three SeHCAT scans will be made, and the difference will be evaluated
Time frame: 7 weeks
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea
Proportions of patients tolerating the treatment and proportion of patients experiencing remission of BAM related diarrhoea within each group will be reported with exact binomial confidence intervals and compared between groups using risk differences and Fisher's exact test.
Time frame: 7 weeks
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