Microscopic colitis Bile acid diarrhea
Conditions
Interventions
Trade Name: Entocort
Product Name: Entocort
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Suspected activity in MC, defined by Hjortswang criteria: 3 stools daily OR one watery (Bristol type 6or7) stools daily, as a mean over the last 6-7 days. Proven microscopic colitis (collagenous, lymphocytic or incomplete) in biopsies from the last 6 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: Age < 18 years Stoma Pregnancy Intestinal resection other than appendectomy cholecystectomy Other chronic intestinal disease with diarrhoea Use of other constipation agent than loperamide Systemic treatment with steroid within 2 weeks of the start of treatment Suspected or proven gastrointestinal infection Allergy to budesonide Lack of compliance or understanding of the trial If taking statin or fibrate therapy: unwilling to pause medical treatment against hypercholesterolaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the prevalence of bile acid diarrhea (BAD) in patients with active microscopic colitis (MC). The apperance of BAD is defined by watery stools and a raised level of 7alpha-hydroxy-4-cholesten-3-on (C4).;Secondary Objective: To investigate the effect of budesonide on the bile acid homeostasis assessed by changes in C4 and FGF19;Primary end point(s): Prevalence of BAD defined by fasting C4 levels > 46 ng/mL in patients with active MC;Timepoint(s) of evaluation of this end point: Analysis of the biobank blood samples after LSLV. Expected aprox. medio 2022 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prevalence of BAD defined by total bile acids > 16 mikromol/g Effect of budesonide on Bile acid diarrhoea as defined above; comparison of prevalence of BAD week 1 and 6. Changes from week 1 (baseline), week 6 (during tratment) and week10 (after treatment) analysed with randomised mixed model: 1. Changes in biomarkers C4, FGF19, total bile acids in spot faecal sample, fractin of primary bile acids in spot faecal sample. 2. Differences between groups MC +BAD and MC - BAD in (a) total bowel movement (week 1,6,10), (b) treatment effect according to modified Hjrotswang criteria, (c) rate of relapse week 6 and 10, (d) changes in HRQol from week 1 to 6: SHS question 1 and 2 and total SHS respectively, (e) GIQLI sum of diarrhoea related questions (item 30,31,36), (f) estimated prevalence of BAD in MC calculated from the sensitivity of C4 as compared with SeHCAT. Prevalence of BAD defined by fasting FGF19 levels 30 ng/mL in patients with active MC Difference in levels of C4 in week 0, 6, and 10 Difference in levels of FGF19 in week 0, 6, and 10 Correlation between difference in C4 and difference in activity Difference in groups with MC with and without BAD with regards to numbers of stools, treatment effects and quality of life index Changes in fractions of primary bile acids in stools (week 0, 6, and 10);Timepoint(s) of evaluation of this end point: Analysis of the biobank blood samples after LSLV. Expected aprox. medio 2023 | — |
Countries
Denmark
Contacts
Public ContactDepartment of Medicine
Zealand University Hospital
Outcome results
None listed