Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— ReMiDy  

Official title:

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883840
• Other study ID #: S63190
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 22, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Tanine Daryoush, MS
• Phone: +3216194080
• Email: tanine.daryoush[@]kuleuven.vib.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Rosuvastatin 10mg
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).

Locations

Country	Name	City	State
Belgium	Imelda Ziekenhuis	Bonheiden	Antwerp
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Vlaams Instituut Biotechnologie (VIB)

Country where clinical trial is conducted

Belgium, 

Outcome

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