Status:
UNKNOWN
A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Relapse in Patients With IBD
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Inflammatory Bowel Diseases
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural cours...
Detailed Description
Inflammatory bowel disease (IBD) is a chronic idiopathic inflammatory condition of the intestine, which results in diarrhea, rectal bleeding, urgency, weight loss and abdominal pain. The natural cours...
Eligibility Criteria
Inclusion
- Patient with Crohn's Disease
- Aged ≥18 years old
- Confirmed diagnosis of ileo-colonic Crohn's disease according to established clinical, endoscopic and histologic criteria
- History of at least one flare with symptoms that required intervention within 24 months before screening
- Stable doses of immunosuppressive agents for at least 3 months if these agents are required
- In clinical remission for at least 3 months, defined as Harvey Bradshaw Index (HBI) score \< 4
- Written informed consent obtained
- Patient with Ulcerative Colitis
- Aged ≥18 years old
- Have a confirmed diagnosis of ulcerative colitis according to established clinical, endoscopic and histologic criteria
- History of at least one flare with symptoms that required intervention within 24 months before screening
- On stable regimen of 5-ASA for at least 3 months
- In clinical remission for at least 3 months defined as partial Mayo score ≤ 1
- Written informed consent obtained
Exclusion
- Previous bowel surgery /stoma
- On anti-TNF therapy
- Malignant disease within 5 years
- Use of probiotics, prebiotics or antibiotics in past 3 months
- Terminal illness
Key Trial Info
Start Date :
January 28 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 28 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04079335
Start Date
January 28 2019
End Date
January 28 2021
Last Update
September 6 2019
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong