Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-20 @ 12:35 PM
Study NCT ID:
NCT03658993
Status:
UNKNOWN
Last Update Posted:
2018-09-06
First Post:
2018-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifaximin-treatment of Collagenous Colitis
Sponsor:
Bonderup, Ole K., M.D.
Organization:
Study Overview
Official Title:
Rifaximin-treatment of Collagenous Colitis:
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XiCoCo
Brief Summary:
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.
Detailed Description:
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: