Back to results

Rifaximin-treatment of Collagenous Colitis (XiCoCo)

Primary Purpose

Collagenous Colitis

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Rifaximin 550 MG

About this trial

This is an interventional treatment trial for Collagenous Colitis focused on measuring Microscopic colitis, Diarrhoea, Microbiome, Rifaxamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rifaxamine 550 mg

Placebo

Arm Description

Study drug Oral Rifaximin 550 mg TID for 4 weeks .

Placebo TID for 4 weeks

Outcomes

Primary Outcome Measures

Clinical remission

The number of patients in clinical remission in the Rifaximin group compared to the placebo group.

Secondary Outcome Measures

Time to relapse.

Time to relapse after cessation of treatment with Rifaxamin compared to placebo

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.

Microbioma

Changes is gut microbiome after treatment

Full Information

NCT ID

NCT03658993

First Posted

September 3, 2018

Last Updated

September 5, 2018

Sponsor

Bonderup, Ole K., M.D.

1. Study Identification

Unique Protocol Identification Number

NCT03658993

Brief Title

Rifaximin-treatment of Collagenous Colitis

Acronym

XiCoCo

Official Title

Rifaximin-treatment of Collagenous Colitis:

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2018 (Anticipated)

Primary Completion Date

November 1, 2020 (Anticipated)

Study Completion Date

November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bonderup, Ole K., M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Collagenous Colitis

Keywords

Microscopic colitis, Diarrhoea, Microbiome, Rifaxamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

A prospective, randomised, double-blind, placebo-controlled trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Randomisation and labelling follow guidelines defined by the Danish Medicines Agency and will be performed by the Hospital Pharmacy Region Midtjylland Clinical Trial Unit, Aarhus University Hospital and Norgine. For equal allocation to the two treatment arms computer generated block randomisation (blocks of 8) will be performed

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rifaxamine 550 mg

Arm Type

Active Comparator

Arm Description

Study drug Oral Rifaximin 550 mg TID for 4 weeks .

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo TID for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Rifaximin 550 MG

Other Intervention Name(s)

Xifaxan

Intervention Description

Oral Rifaximin 550 mg TID for 4 weeks.

Primary Outcome Measure Information:

Title

Clinical remission

Description

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

Secondary Outcome Measure Information:

Title

Time to relapse.

Description

Time to relapse after cessation of treatment with Rifaxamin compared to placebo

Time Frame

Last visit is one year after treatment cessation.

Title

Difference in Quality of life: short health scale (SHS)

Description

Time Frame

12 weeks after treatment

Title

Microbioma

Description

Changes is gut microbiome after treatment

Time Frame

12 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ole K Bonderup, PhD

Phone

004520212579

olebonde@rm.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Sabine Becker, MD

sabbec@rm.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabine K Becker, MD

Organizational Affiliation

Clinic of Gastrointestinal- and Infectious Diseases, Diagnostic Center Silkeborg Regional Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Within 6 months of study completion

IPD Sharing Access Criteria

Requestors will be required to sign a Data Access Agreement

Learn more about this trial

Rifaximin-treatment of Collagenous Colitis

We'll reach out to this number within 24 hrs