Ulcerative Colitis Clinical Trial
— ReMiDyOfficial title:
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
- Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) - Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients. - Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients. - Evaluation of reduced inflammatory parameters of participants involved in trial
Status | Recruiting |
Enrollment | 220 |
Est. completion date | December 31, 2023 |
Est. primary completion date | November 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - General criteria - Bact2 enterotyped one month before start of study intervention (at least 150 of enrolled participants must meet this 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 - Patients in remission (mayo score below 4) or with currently mild to moderate active ulcerative colitis (defined by Mayo score of 4-10), despite stable medication (8 weeks) and a Mayo endoscopic sub-score 2- 3 at week 0 Criteria specific to healthy Bact2 participants - Individuals with no physician diagnosed diseases or disorders Exclusion Criteria: - General criteria - Prior and/or ongoing use of statins before study start - History of surgical intervention in gastrointestinal tract (appendectomies are allowed) - Females who are pregnant or actively trying to become pregnant - Individuals with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN) - Lactose intolerance - Pre-diabetic participants - Personal or family history of hereditary muscular disorders - Individuals with a history of or diagnosed with alcohol abuse Criteria specific to UC patients - Other conditions leading to profound immunosuppression such as HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis - A diagnosis of Crohn's disease or indeterminate colitis - Individuals with hypothyroidism - Individuals with a diagnosis of diabetes mellitus - Individuals with severe renal impairment (creatinine clearance <30 ml/min) - Individuals with myopathy - Participants who have taken antibiotics sometime in the past four months - Use of antibiotics one month prior to week 0 - Steroid dependency and requiring >16mg Medrol (methyl prednisone) or equivalent two week before week 0 Criteria specific to healthy Bact2 participants - Participants with family history of autoimmune chronic inflammatory diseases like multiple sclerosis, IBD, and rheumatoid arthritis |
Country | Name | City | State |
---|---|---|---|
Belgium | Imelda Ziekenhuis | Bonheiden | Antwerp |
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | Vlaams Instituut Biotechnologie (VIB) |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | UC Mayo Score | Decrease P partial mayo by one point or stays in remission during experimental intervention when taking IMP | 8 weeks | |
Primary | Systemic inflammatory measures | significant and substantial change in hs-CRP when taking IMP | 8 weeks | |
Primary | Local inflammatory measures | significant and substantial change fecal calprotectin when taking IMP | 8 weeks | |
Secondary | Significant change in gastrointestinal microbiome composition | Change away from dysbiotic enterotype to eubiotic one when taking IMP | 8 weeks |
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