search
Back to results

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis (ReMiDy)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Rosuvastatin 10mg
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Microbiome, Dysbiosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Imelda Ziekenhuis
  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Rosuvastatin 10 mg

Arm Description

Outcomes

Primary Outcome Measures

UC Mayo Score
Decrease P partial mayo by one point or stays in remission during experimental intervention when taking IMP
Systemic inflammatory measures
significant and substantial change in hs-CRP when taking IMP
Local inflammatory measures
significant and substantial change fecal calprotectin when taking IMP

Secondary Outcome Measures

Significant change in gastrointestinal microbiome composition
Change away from dysbiotic enterotype to eubiotic one when taking IMP

Full Information

First Posted
May 6, 2021
Last Updated
January 19, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vlaams Instituut Biotechnologie (VIB)
search

1. Study Identification

Unique Protocol Identification Number
NCT04883840
Brief Title
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
Acronym
ReMiDy
Official Title
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
November 22, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Vlaams Instituut Biotechnologie (VIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Microbiome, Dysbiosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Rosuvastatin 10 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10mg
Intervention Description
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).
Primary Outcome Measure Information:
Title
UC Mayo Score
Description
Decrease P partial mayo by one point or stays in remission during experimental intervention when taking IMP
Time Frame
8 weeks
Title
Systemic inflammatory measures
Description
significant and substantial change in hs-CRP when taking IMP
Time Frame
8 weeks
Title
Local inflammatory measures
Description
significant and substantial change fecal calprotectin when taking IMP
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Significant change in gastrointestinal microbiome composition
Description
Change away from dysbiotic enterotype to eubiotic one when taking IMP
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanine Daryoush, MS
Phone
+3216194080
Email
tanine.daryoush@kuleuven.vib.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severine Vermeire, MD & PhD
Organizational Affiliation
KU/UZ Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeroen Raes, PhD
Organizational Affiliation
KU Leuven/VIB
Official's Role
Study Director
Facility Information:
Facility Name
Imelda Ziekenhuis
City
Bonheiden
State/Province
Antwerp
ZIP/Postal Code
2820
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bossuyt, MD
Email
peter.bossuyt@imelda.be
First Name & Middle Initial & Last Name & Degree
Hanne Boey
Email
hanne.boey@imelda.be
First Name & Middle Initial & Last Name & Degree
Peter Bossuyt, MD
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Nigro, MS
Email
melissa.nigro@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Tanine Daryoush, MS
Phone
+3216194080
Ext
Vermeire
Email
severine.vermeire@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Severine Vermeire, MD & PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

We'll reach out to this number within 24 hrs