A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With CD
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|ClinicalTrials.gov Identifier: NCT03994224|
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 11, 2019
Crohn's disease (CD) is a chronic relapsing-remitting systemic inflammatory disease, affecting any part of the gastrointestinal tract. Biological therapy with anti-tumor necrosis factor (TNF) alpha is the established treatment of choice for the management of moderate to severe Crohn's disease. However, its efficacy in an individual patient is the unpredictable and long-term outcome is still suboptimal. Identifying biomarkers which can predict treatment response is thus of utmost importance and can allow personalized management.
In inflammatory bowel disease (IBD), altered fecal microbiota signatures have been consistently reported. Moreover, overall bacterial diversity is consistently decreased during intestinal inflammation.
Fecal calprotectin (FC) is a calcium and zinc binding protein largely confined to the neutrophil granulocytes and macrophages and is a very sensitive marker for detection of inflammation in the gastrointestinal tract.
C reactive protein (CRP) is an acute phase reactant. CD Patients with elevated baseline CRP levels responded to infliximab treatment better and early normalisation of CRP correlated with sustained long-term response to infliximab therapy.
The investigators hypothesize that faecal microbial signatures in conjunction with faecal calprotectin and CRP may have a role in predicting response to biological therapy in CD patients.
|Condition or disease|
|Crohn Disease Perianal Crohn Disease|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With Crohn's Disease|
|Actual Study Start Date :||February 18, 2019|
|Estimated Primary Completion Date :||February 18, 2021|
|Estimated Study Completion Date :||February 18, 2021|
- Asymptomatic Crohn's Disease patients [ Time Frame: 2 years ]Defined as normal CRP level <10mg/l and no use of corticosteroid in the last 4 weeks.
- Asymptomatic perianal Crohn's Disease patients [ Time Frame: 2 years ]Defined as the absence of draining fistula on two consecutive visits according to Fistula Drainage Assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994224
|Contact: Jessica Ching||+852 firstname.lastname@example.org|
|Contact: Alicia Chan||+852 email@example.com|
|Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Siew Chien Ng, PhD|
|Principal Investigator:||Siew Chien Ng, Prof||Chinese University of Hong Kong|