Collagenous ColitisPhase 3XiCoCoNCT03658993
Rifaximin-treatment of Collagenous Colitis
A Phase 3 study testing Rifaximin 550 MG in people with Collagenous Colitis, run by Bonderup, Ole K., M.D..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Collagenous Colitis
- What is being tested?
- Rifaximin 550 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- - 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
Show all 14Show fewer
- 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)
Trial locations and contacts
No sites are listed yet.
Sabine Becker, MD contact
About this study
Official title: Rifaximin-treatment of Collagenous Colitis:
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.
Read the 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.
- Conditions
- Collagenous Colitis
- Being tested
- Rifaximin 550 MG
- Keywords
- Microscopic colitis, Diarrhoea, Microbiome, Rifaxamine
- Medical subject headings
- Colitis, Collagenous, Colitis, Microscopic, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 550 MGDrug
Also called Xifaxan
Oral Rifaximin 550 mg TID for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rifaxamine 550 mg | Active comparator | Study drug Oral Rifaximin 550 mg TID for 4 weeks . Receives: Drug: Rifaximin 550 MG |
| Placebo | Placebo comparator | Placebo TID for 4 weeks Receives: Drug: Rifaximin 550 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
The number of patients in clinical remission in the Rifaximin group compared to the placebo group.
Measured: The number of patients in clinical remission 12 weeks after randomisation
Secondary outcomes (3)
Time to relapse.
Time to relapse after cessation of treatment with Rifaxamin compared to placebo
Measured: 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.
Measured: 12 weeks after treatment
Microbioma
Changes is gut microbiome after treatment
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagenous ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomised, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bonderup, Ole K., M.D.
- Responsible party
- Sponsor
- Investigators
- Sabine K Becker, MD, Principal investigator, Clinic of Gastrointestinal- and Infectious Diseases, Diagnostic Center Silkeborg Regional Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658993
- Sponsor's protocol ID
- BonderupO
- Acronym
- XiCoCo
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifaximin-treatment of Collagenous Colitis:
- ClinicalTrials.gov ID
- NCT03658993
- Acronym / sponsor ID
- XiCoCo / BonderupO
- Conditions
- Collagenous Colitis
- Keywords
- Microscopic colitis, Diarrhoea, Microbiome, Rifaxamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bonderup, Ole K., M.D.
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomised, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rifaxamine 550 mg | Active comparator | Drug: Rifaximin 550 MGStudy drug Oral Rifaximin 550 mg TID for 4 weeks . |
| Placebo | Placebo comparator | Drug: Rifaximin 550 MGPlacebo TID for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Signed informed consent
Key exclusion criteria (14 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifaximin 550 MGAlso: XifaxanOral Rifaximin 550 mg TID for 4 weeks. | Drug | Placebo, Rifaxamine 550 mg |
Primary outcome
Clinical remission
Time frame: The number of patients in clinical remission 12 weeks after randomisation
The number of patients in clinical remission in the Rifaximin group compared to the placebo group.
3 secondary outcomes
Time to relapse.
Time frame: Last visit is one year after treatment cessation.
Difference in Quality of life: short health scale (SHS)
Time frame: 12 weeks after treatment
Microbioma
Time frame: 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Becker, MD contact
Sabine K Becker, MD principal investigator
Clinic of Gastrointestinal- and Infectious Diseases, Diagnostic Center Silkeborg Regional Hospital, Falkevej 1-3, 8600 Silkeborg, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifaximin 550 MG in people with Collagenous Colitis, run by Bonderup, Ole K., M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ole K Bonderup, PhD (004520212579, olebonde@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: The number of patients in clinical remission 12 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.