Rifaximin-treatment of Collagenous Colitis

Collagenous Colitis Clinical Trial

— XiCoCo  

Official title:

Rifaximin-treatment of Collagenous Colitis:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03658993
• Other study ID #: BonderupO
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2018
• Source: Bonderup, Ole K., M.D.
• Contact: Ole K Bonderup, PhD
• Phone: 004520212579
• Email: olebonde[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Signed informed consent

• Histological findings fulfill criteria for CC:

• A subepithelial collagenous band >10 µm in colonic biopsies

• Increased count of inflammatory cells in lamina propria

• Diagnostic biopsies are a maximum of two years old

• A history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed CC or a history of clinical relapse for more than a week in patients with known CC

• Active disease: > 3 stools/day or >1 watery stool/day measured as a mean during a week prior to baseline

Exclusion Criteria:

• - Significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps < 2 cm are not considered significant findings)

• Biopsies more than two years old in a patient, who does not accept a new sigmoidoscopy

• Untreated celiac disease

• Positive stool cultures for pathogenic intestinal bacteria including Clostridium difficile

• Suspected colitis induced by medication (diarrhea shortly after commencement of NSAID's, statins, SSRI or PPI)

• Severe comorbidity (cardiovascular, renal, endocrine, neurologic, pulmonal or psychiatric) or history of cancer during the last 5 years

• Abnormal liver biochemistry (ALAT or ALP > 2,5 x upper limit), cirrhosis or portal hypertension

• Pregnancy or lactation (assured by negative P-hCG at inclusion)

• History of significant intestinal resection

• Treatment with 5-ASA, Salazopyrin, immunemudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), local or systemic glucocorticoids (except for Budesonide) within the last three month

• Allergy or intolerance to Rifaximin (or similar antibiotics such as Rifampicin or Rifabutin)

• Expectation of lack of cooperation or insufficient comprehension

• Concomitant participation in an other clinical trial or participation within the last 30 days

• Patients receiving Warfarin or Marcoumar (interaction with risk of uncontrolled INR-levels)

Related Conditions & MeSH terms

• Colitis
• Collagenous Colitis

Intervention

Drug:
• Rifaximin 550 MG
Oral Rifaximin 550 mg TID for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bonderup, Ole K., M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission	The number of patients in clinical remission in the Rifaximin group compared to the placebo group.	The number of patients in clinical remission 12 weeks after randomisation
Secondary	Time to relapse.	Time to relapse after cessation of treatment with Rifaxamin compared to placebo	Last visit is one year after treatment cessation.
Secondary	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.	12 weeks after treatment
Secondary	Microbioma	Changes is gut microbiome after treatment	12 weeks after treatment