Development of Novel Fecal Microbial Biomarkers for Inflammatory Bowel Disease

Summary

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and Ulcerative colitis (UC), is a chronic idiopathic inflammatory condition of the intestine. Endoscopy has been used to monitor the disease, but it is time-consuming, costly, invasive, and associated with certain risks of morbidity. Many patients are reluctant to undergo repeated endoscopic examinations, particularly when their disease is quiescent. Acute phase reactants have been used to monitor disease including C-reactive protein and stool leucocyte markers including fecal calprotectin, but their sensitivity and specificity in correlating to intestinal inflammation activity are low. Clinical challenge of patient heterogeneity in disease phenotype and response to therapy has compounded discovery of disease-related biomarkers. In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members. Moreover, overall bacterial diversity is consistently decreased in IBD patients compared to controls. Even though a number of fecal biomarkers have been evaluated for their utility for disease diagnosis in IBD, to date none has been accurate enough for clinical application. Therefore, identification and validation of a non-invasive biomarker which can be easily applied in disease diagnosis and prognosis is warranted to provide an earlier opportunity to intervene. In this study, it aims to develop a metagenomics-based model using fecal microbial biomarkers for differentiating IBD patients from healthy controls, and then validate these fecal microbial biomarkers in different populations.

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn Disease
• Microbiome

Sponsors & Collaborators

• National Taiwan University

  collaborator OTHER

• Hanoi Medical University

  collaborator OTHER

• Mahidol University

  collaborator OTHER

• Indonesia University

  collaborator OTHER

• National University of Malaysia

  collaborator OTHER

• Kiang Wu Hospital

  collaborator OTHER

• National Academy of Medical Sciences, Nepal

  collaborator OTHER_GOV

• Duke-NUS Graduate Medical School

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Heidelberg University

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Chinese University of Hong Kong

  lead OTHER

Principal Investigators

• Siew Chien Ng, PhD · Chinese University of Hong Kong

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-07

Primary Completion

2024-07-31

Completion

2024-07-31

Countries

• Hong Kong

Study Locations