The hypothesis of this study is that an altered gut microbiota is a contributory factor in initiating an inflammatory process in the colonic mucosa leading to collagenous colitis. The investigators suggest that treatment with budesonide reduces the inflammation without treating the underlying cause. In this trial the investigators will try to modullate gut microbiota by adding rifaximin. The aim of this study is to assess if 4 weeks treatment with rifaximin as a supplement to a standard course of budesonide against active CC can reduce the risk of relapse after treatment cessation.
Patients with biopsy-verified CC and active disease defined by \>3 bowel movements/day or \>1 watery stool measured as a mean for a week. Patients will be invited to participate in the study independently of age and disease duration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Oral Rifaximin 550 mg TID for 4 weeks.
Clinical remission
The number of patients in clinical remission in the Rifaximin group compared to the placebo group.
Time frame: The number of patients in clinical remission 12 weeks after randomisation
Time to relapse.
Time to relapse after cessation of treatment with Rifaxamin compared to placebo
Time frame: Last visit is one year after treatment cessation.
Difference in Quality of life: short health scale (SHS)
Difference in Quality of life assessed by a visual analog scale (SHS) after cessation of treatment with Rifaxamin compared to placebo. The scale extends from 0 to 10 with 0 as worst outcome and 10 as best outcome.
Time frame: 12 weeks after treatment
Microbioma
Changes is gut microbiome after treatment
Time frame: 12 weeks after treatment
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