Invloed van UDCA op fecale galzoutensamenstelling van IBD patiënten: piloot studie.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003141-10-BE

Enrollment

Registered

2014-09-26

Start date

2014-09-29

Completion date

Unknown

Last updated

2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease or colitis ulcerosa MedDRA version: 17.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: UrsoFalk® 250 mg tabletten. Product Name: UrsoFalk Pharmaceutical Form: Tablet INN or Proposed INN: ursodeoxycholic acid CAS Number: 128-13-2 Other descriptive name: URSODEOXYCHOLIC ACID C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Control group: - age between 18-65 yrs - abscence of important gastrointestinal co-morbidity IBD group: - Crohn's disease or Colitis ulcerosa - Active disease at inclusion (CDAI = 150 or UCDAI = 3) IBD remission group: - Crohn's disease or Colitis ulcerosa - Clinical remission (CDAI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Control group : - bile salt modulating medication (e.g. Questran) - cholecystectomy - important gastroinestinal co-morbidity - previous treatment with Ursodeoxycholic acid - antibiotic intake within 1 month of this study Active IBD group: - bile salt modulating medication (e.g. Questran) - cholecystectomy - previous treatment with Ursodeoxycholic acid - antibiotic intake within 1 month of this study IBD remission group: - bile salt modulating medication (e.g. Questran) - cholecystectomy - Treatment with Ursodeoxycholic acid within 1 month prior to study - antibiotic intake within 3 months of this study

Design outcomes

Primary

Measure	Time frame
Main Objective: To research the effects of UDCA administration on the fecal metabolites (especially bile salts) and fecal microbiota of IBD patients and healthy volunteers.;Secondary Objective: To research the effects of UDCA administration on the symptoms and intestinal inflammation in IBD patients.;Primary end point(s): - Change in fecal metabolite composition (especially bile salts) - Change in fecal microbiota composition ;Timepoint(s) of evaluation of this end point: Until 4 weeks after start of study.	—

Measure

Time frame

Main Objective: To research the effects of UDCA administration on the fecal metabolites (especially bile salts) and fecal microbiota of IBD patients and healthy volunteers.;Secondary Objective: To research the effects of UDCA administration on the symptoms and intestinal inflammation in IBD patients.;Primary end point(s): - Change in fecal metabolite composition (especially bile salts) - Change in fecal microbiota composition ;Timepoint(s) of evaluation of this end point: Until 4 weeks after start of study.

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Secondary

Measure	Time frame
Secondary end point(s): - Tolerability of UDCA administration (adverse effects) - Change in CDAI/UCDAI score, calprotectin levels ;Timepoint(s) of evaluation of this end point: Until 4 weeks after start of study.	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026