Microscopic Colitis Clinical Trial
Official title:
Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis: A Prospective, Randomized, Active Comparator Pilot Study
The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX [Cortiment] and budesonide CR [Entocort]) work for treating patients with microscopic colitis.
After being informed of the study and potential risks, patients with symptomatically active microscopic colitis who provide written informed consent will undergo a 4-week screening period to determine their eligibility for the study. At week 0, eligible patients will be randomized in a single blind manner (patients will be aware, while investigators will be blinded) in a 1:1 ratio to budesonide MMX (9mg once daily) or budesonide CR (3mg three times daily). The total treatment duration will be for 8 weeks. The primary outcome will be clinical remission, defined by the Hjortswang criteria (daily average <3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05998174 -
Faecal Microbiota Transplantation for Microscopic Colitis
|
Early Phase 1 | |
Recruiting |
NCT05058131 -
Modulation of Intestinal Barrier Function and Inflammation Via Butyrate-promoting Dietary Fibre
|
N/A | |
Completed |
NCT02303132 -
Ussing Experiments to Evaluate the Role of Medication-induced Microscopic Colitis
|
N/A | |
Terminated |
NCT05579444 -
Systems Biology of Gastrointestinal and Related Diseases
|
||
Recruiting |
NCT06031064 -
External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea
|
||
Recruiting |
NCT04043897 -
Efficacy and Safety of Oral Rifaximin in Patients With Active Microscopic Colitis
|
Phase 2 | |
Recruiting |
NCT06172647 -
Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer
|
||
Recruiting |
NCT03477032 -
FMT in Inflammatory Bowel Disease
|
||
Completed |
NCT03275467 -
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
|
N/A | |
Completed |
NCT01928667 -
Case-Control Study to Identify Risk Factors for Microscopic Colitis
|
N/A | |
Completed |
NCT00180050 -
Budesonide Treatment for Lymphocytic Colitis
|
Phase 3 | |
Completed |
NCT00952952 -
Trial of Mesalamine for the Treatment of Active Microscopic Colitis
|
Phase 2/Phase 3 |