Ulcerative Colitis
Conditions
Keywords
Microbiome, Dysbiosis
Brief summary
* Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) * Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.
Interventions
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).
Sponsors
Vlaams Instituut Biotechnologie (VIB)
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant change in gastrointestinal microbiome composition | 8 weeks | Change away from dysbiotic enterotype to eubiotic one when taking IMP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| UC Mayo Score / CDAI | 8 weeks | Significant improvement in UC patient overall disease status characterised by reduction of at least 3 points in the non-invasive Mayo Score and by a full point reduction in the endoscopic subscore. Similarly, significant improvement in CD patient overall disease status characterised by reduction of the Crohn's disease activity index (CDAI) by at least 70 points or by a CDAI score \< 150 |
Countries
Belgium
Outcome results
None listed