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

Phase 1

• Conditions: Crohn's disease or colitis ulcerosa; MedDRA version: 17.1Level: PTClassification code 10009900Term: Colitis ulcerativeSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-003141-10-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-26
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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 < 150 or UCDAI = 2)

Inclusiecriteria PSC groep
- Gekende PSC
- Chronische behandeling met UDCA

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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified