Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Study Purpose

  • - 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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04883840
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Universitaire Ziekenhuizen KU Leuven
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Severine Vermeire, MD & PhDJeroen Raes, PhD
Principal Investigator Affiliation KU/UZ LeuvenKU Leuven/VIB
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Placebo Comparator: Placebo

Experimental: Rosuvastatin 10 mg

Interventions

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Imelda Ziekenhuis, Bonheiden, Antwerp, Belgium

Status

Not yet recruiting

Address

Imelda Ziekenhuis

Bonheiden, Antwerp, 2820

Site Contact

Peter Bossuyt, MD

peter.bossuyt@imelda.be

+3216194080

UZ Leuven, Leuven, Vlaams-Brabant, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, Vlaams-Brabant, 3000

Site Contact

Melissa Nigro, MS

melissa.nigro@uzleuven.be

+3216194080