Could a common cholesterol drug tame inflammatory bowel disease?
NCT ID NCT04883840
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether statins, a common cholesterol drug, could change the gut bacteria in people with ulcerative colitis or Crohn's disease to a healthier type. The goal was to see if this change could reduce disease activity. The study was terminated early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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177 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 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 Exclusion criteria 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Delta
Roeselare, West-Vlaanderen, 8800, Belgium
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Imelda Ziekenhuis
Bonheiden, Antwerp, 2820, Belgium
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UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
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Other studies related to the condition(s) this trial covers.
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