Rifaximin-treatment of Collagenous Colitis

NCT03658993 | Unknown Phase 3

• 1 other identifier: BonderupO
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Collagenous Colitis

Keywords

Microscopic colitis; Diarrhoea; Microbiome; Rifaxamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to relapse.

  Last visit is one year after treatment cessation.

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

  12 weeks after treatment

• Microbioma

  12 weeks after treatment

Study Arms (2)

Rifaxamine 550 mg

ACTIVE COMPARATOR

Study drug Oral Rifaximin 550 mg TID for 4 weeks .

Drug: Rifaximin 550 MG

Placebo

PLACEBO COMPARATOR

Placebo TID for 4 weeks

Drug: Rifaximin 550 MG

Interventions

Rifaximin 550 MG DRUG

Oral Rifaximin 550 mg TID for 4 weeks.

Also known as: Xifaxan

Placebo; Rifaxamine 550 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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
• 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)

Sponsors & Collaborators

• Bonderup, Ole K., M.D.: lead

MeSH Terms

Conditions

Colitis, Collagenous; Colitis, Microscopic; Diarrhea

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Sabine K Becker, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole K Bonderup, PhD

CONTACT

004520212579; olebonde@rm.dk

Sabine Becker, MD

CONTACT

sabbec@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: A prospective, randomised, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: September 6, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2021
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of study completion
• Access Criteria: Requestors will be required to sign a Data Access Agreement