Development of Novel Fecal Microbial Biomarkers for Inflammatory Bowel Disease

NCT05598489 | Unknown DMC

• 1 other identifier: IBDFMB
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Fecal microbial biomarkers for IBD

  To identify and develop fecal microbial biomarkers for IBD, and validate fecal microbial biomarkers in different populations

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases (Crohn's disease or Ulcerative colitis) and healthy controls

You may qualify if:

• Aged ≥18 years old
• Confirmed diagnosis of Crohn's disease or Ulcerative colitis defined by endoscopy, radiology, and histology
• Competent to provide informed consent

You may not qualify if:

• Use of antibiotics in the last 1 month
• Known current sepsis (excluding uncomplicated infections such as influenza)
• Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)
• Major bowel surgery in the last 6 months (excluding colonoscopy/ procedure related to perianal disease)
• Presence of an ileostomy / stoma
• Current pregnancy
• Aged ≥18 years old
• No known medical history including inflammatory bowel disease, irritable bowel syndrome or GI malignancy
• Competent to provide informed consent
• Use of antibiotics in the last 1 month
• Known current sepsis (excluding uncomplicated infections such as influenza)
• Known history of severe organ failure (including decompensated cirrhosis, malignant disease, kidney failure, epilepsy, active serious infection, acquired immunodeficiency syndrome)
• Bowel surgery in the last 6 months (excluding colonoscopy/ procedure related to perianal disease)
• Presence of an ileos

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• National Taiwan University: collaborator
• Hanoi Medical University: collaborator
• Mahidol University: collaborator
• Indonesia University: collaborator
• National University of Malaysia: collaborator
• Kiang Wu Hospital: collaborator
• National Academy of Medical Sciences, Nepal: collaborator
• Duke-NUS Graduate Medical School: collaborator
• National University Hospital, Singapore: collaborator
• Heidelberg University: collaborator
• University of Chicago: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will collect fresh stool in a stool container. Stool DNA will be extracted and stored until used.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Siew Chien Ng, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siew Chien Ng, PhD

CONTACT

852-35053996; siewchienng@cuhk.edu.hk

Jingwan Zhang, PhD

CONTACT

852-39798632; wendyjwzhang@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: December 7, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

HK (1)