Ulcerative ColitisPhase 2/3ReMiDyNCT04883840
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
A Phase 2/3 study testing Rosuvastatin 10mg in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial summary
Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Rosuvastatin 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 3 sitesBelgium
- Study dates
- 22 Oct 2020to 11 Oct 2025
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General criteria Willingness to participate in the study and to sign the informed consent (Dutch) Between 18 and 70 years old Access to a -20°C freezer
- Criteria specific to UC patients In clinical remission (total Mayo Score below 4) or with currently mild to moderate active ulcerative colitis (Mayo Score between 4-10 and endoscopic sub score 2-3 at week 0), either untreated or under stable medication
- Criteria specific to CD patients In clinical remission (CDAI score below 150 at week 0) or with currently mild active Crohn's disease (CDAI score between 150-220 at week 0), either untreated or under stable medication
Who cannot join
- General criteria Prior and/or ongoing use of statins Females who are pregnant, actively trying to become pregnant, or are not using effective anticonception measures Active liver disease or liver damage including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN) Prediabetes Personal or family history of or diagnosed with hereditary muscular disorders History of or diagnosed with alcohol abuse Use of antibiotics at any time in the four weeks before the start of the intervention (UC \& CD patients Participation in simultaneously occurring clinical trials
- Criteria specific to CD \& UC patients Any surgical intervention in the gastrointestinal tract (with the exception of an appendectomy in all participants or ileocecal resections, cholecystectomy, fistulectomy, strictureplasty and abscess drainage in CD patients.) Severe renal impairment (creatinine clearance <30 ml/min) Diabetes mellitus Hypothyroidism Myopathy Other conditions leading to profound immunosuppression such as HIV, infectious diseases, bone marrow malignancies, and liver cirrhosis Use of methotrexate or calcineurin inhibitors Indeterminate colitis Steroid dependency, i.e., requiring more than 16mg Medrol (methyl prednisone) or an equivalent steroid two weeks before week 0
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Imelda Ziekenhuis
Bonheiden, Antwerp, 2820
UZ Leuven
Leuven, Vlaams-Brabant, 3000
AZ Delta
Roeselare, West-Vlaanderen, 8800
About this study
- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
- Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.
- Conditions
- Ulcerative Colitis
- Being tested
- Rosuvastatin 10mg
- Keywords
- Microbiome, Dysbiosis
- Medical subject headings
- Colitis, Ulcerative, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 10mgDrug
Daily dose of one medication over 8 week period then switch to another medication over an 8 week period (type of medication during each intervention period is blinded and then randomized).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Rosuvastatin 10mg |
| Rosuvastatin 10 mg | Experimental | Not described Receives: Drug: Rosuvastatin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant change in gastrointestinal microbiome composition
Change away from dysbiotic enterotype to eubiotic one when taking IMP
Measured: 8 weeks
Secondary outcomes (1)
UC Mayo Score / CDAI
Significant improvement in UC patient overall disease status characterised by reduction of at least 3 points in the non-invasive Mayo Score and by a full point reduction in the endoscopic subscore. Similarly, significant improvement in CD patient overall disease status characterised by reduction of the Crohn's disease activity index (CDAI) by at least 70 points or by a CDAI score < 150
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start22 Oct 2020
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Why it stopped: Due to the university's termination of its contract with the online questionnaire platform, we decided to discontinue the study before reaching the anticipated sample size.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
- Investigators
- Severine Vermeire, MD & PhD, Principal investigator, KU/UZ LeuvenJeroen Raes, PhD, Study director, KU Leuven/VIB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883840
- Sponsor's protocol ID
- S63190
- Acronym
- ReMiDy
- Status last verified
- Oct 2025
- First submitted
- 6 May 2021
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT04883840
- Acronym / sponsor ID
- ReMiDy / S63190
- Conditions
- Ulcerative Colitis
- Keywords
- Microbiome, Dysbiosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the university's termination of its contract with the online questionnaire platform, we decided to discontinue the study before reaching the anticipated sample size.
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Flemish institute of biotechnology (VIB)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 12 May 2021 (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.
- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
- Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Rosuvastatin 10mg |
| Rosuvastatin 10 mg | Experimental | Drug: Rosuvastatin 10mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- General criteria Willingness to participate in the study and to sign the informed consent (Dutch) Between 18 and 70 years old Access to a -20°C freezer
- Criteria specific to UC patients In clinical remission (total Mayo Score below 4) or with currently mild to moderate active ulcerative colitis (Mayo Score between 4-10 and endoscopic sub score 2-3 at week 0), either untreated or under stable medication
- Criteria specific to CD patients In clinical remission (CDAI score below 150 at week 0) or with currently mild active Crohn's disease (CDAI score between 150-220 at week 0), either untreated or under stable medication
Key exclusion criteria (2 listed)
- General criteria Prior and/or ongoing use of statins Females who are pregnant, actively trying to become pregnant, or are not using effective anticonception measures Active liver disease or liver damage including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN) Prediabetes Personal or family history of or diagnosed with hereditary muscular disorders History of or diagnosed with alcohol abuse Use of antibiotics at any time in the four weeks before the start of the intervention (UC \& CD patients Participation in simultaneously occurring clinical trials
- Criteria specific to CD \& UC patients Any surgical intervention in the gastrointestinal tract (with the exception of an appendectomy in all participants or ileocecal resections, cholecystectomy, fistulectomy, strictureplasty and abscess drainage in CD patients.) Severe renal impairment (creatinine clearance <30 ml/min) Diabetes mellitus Hypothyroidism Myopathy Other conditions leading to profound immunosuppression such as HIV, infectious diseases, bone marrow malignancies, and liver cirrhosis Use of methotrexate or calcineurin inhibitors Indeterminate colitis Steroid dependency, i.e., requiring more than 16mg Medrol (methyl prednisone) or an equivalent steroid two weeks before week 0
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 |
|---|---|---|
| Rosuvastatin 10mgDaily dose of one medication over 8 week period then switch to another medication over an 8 week period (type of medication during each intervention period is blinded and then randomized). | Drug | Placebo, Rosuvastatin 10 mg |
Primary outcome
Significant change in gastrointestinal microbiome composition
Time frame: 8 weeks
Change away from dysbiotic enterotype to eubiotic one when taking IMP
1 secondary outcome
UC Mayo Score / CDAI
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Due to the university's termination of its contract with the online questionnaire platform, we decided to discontinue the study before reaching the anticipated sample size.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Severine Vermeire, MD & PhD principal investigator
KU/UZ Leuven
Jeroen Raes, PhD study director
KU Leuven/VIB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rosuvastatin 10mg in people with Ulcerative Colitis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study was stopped early (reason given: Due to the university's termination of its contract with the online questionnaire platform, we decided to discontinue the study before reaching the anticipated sample size.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant change in gastrointestinal microbiome composition (time frame: 8 weeks). 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 25 Nov 2025; AzTrials last refreshed its copy on 30 Oct 2026.