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A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With CD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994224
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive CD subjects who visit Prince of Wales Hospital in Hong Kong
Criteria

Inclusion Criteria:

Patients with moderate to severe Crohn's disease

  1. Aged ≥ 18 years old
  2. Confirmed diagnosis of Crohn's disease according to established clinical, endoscopic and histological criteria
  3. Moderate to severe Crohn's disease who are due to start biological therapy
  4. Written informed consent obtained

Subjects with perianal Crohn's disease

  1. Aged ≥ 18 years old
  2. Confirmed diagnosis of Crohn's disease with perianal involvement according to established clinical, endoscopic and histological criteria
  3. Subjects with active perianal Crohn's disease who are due to start biological therapy
  4. Written informed consent obtained

4.2. Exclusion Criteria

  1. Previous bowel surgery/ stoma
  2. History of anti-TNF use in the last 3 months
  3. Malignant disease within 5 years
  4. Use of probiotics, prebiotics or antibiotics in the past 1 months

Information from the National Library of Medicine

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


Contacts
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Contact: Jessica Ching +852 35053524 jessicaching@cuhk.edu.hk
Contact: Alicia Chan +852 26373260 aliciachan@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Siew Chien Ng, PhD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Chien Ng, Prof Chinese University of Hong Kong
Publications:

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Responsible Party: Siew Chien NG, Profressor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03994224    
Other Study ID Numbers: CD MiRES
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases