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NCT05598489
Development of Novel Fecal Microbial Biomarkers for Inflammatory Bowel Disease
trial in Inflammatory Bowel Diseases in 3,300 participants. Status unknown.
31 July 2024
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 3,300 |
| Start date | 7 December 2022 |
| Primary completion | 31 July 2024 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across Hong Kong |
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Crohn Disease — all drugs for Crohn Disease →
- Microbiome — all drugs for Microbiome →
Sponsor
Chinese University of Hong Kong
Who can join
18 and older, any sex, with Inflammatory Bowel Diseases or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05598489
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05598489 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 31 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05598489.
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