Status:
UNKNOWN
Stratifying Crohn's Using Biomarker Assessment
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Crohn Disease in Remission
Eligibility:
All Genders
18-50 years
Brief Summary
Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than i...
Detailed Description
Crohn's disease (CD) is a relapsing and remitting condition requiring lifelong monitoring. Stool sampling for disease monitoring in inflammatory bowel disease (IBD) is non-invasive, cost-effective an...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of luminal CD by standard endoscopic, histological or radiological criteria
- In clinical remission as defined by Harvey Bradshaw Index (HBI) \<4
- Aged 18-50
- On any CD-related therapy or indeed no therapy
- Having FC checked anyway to monitor mucosal disease activity
Exclusion
- Isolated perianal or upper GI CD
- Short gut syndrome necessitating total parenteral nutrition (TPN); otherwise patients with stomas allowed.
- Current or previous colorectal carcinoma or high-risk adenoma, active diverticular disease (diverticulitis) or haemorrhoids
- Ulcerative or indeterminate colitis
- Patients taking NSAIDs, warfarin, heparin, anti-platelet therapy or DOACs.
Key Trial Info
Start Date :
August 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04321863
Start Date
August 13 2020
End Date
July 1 2022
Last Update
October 8 2020
Active Locations (1)
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1
Glasgow Royal Infirmary
Glasgow, United Kingdom, G40SF