Clinical trial · Observational
Serial Gut Microbiome and Bacterial Gene Markers Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
A Pilot Study to Assess Serial Gut Microbiome and a Panel of Bacterial Gene Markers (M3) Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
NCT05381792CI-TRIAL-00080195M3-CANunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators hypothesize that gut microbiome composition and the four bacterial gene markers (M3) show dynamic changes after endoscopic resection of advanced neoplasia, some key bacteria are associated with restoration of gut microbiome after endoscopic resection.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bacterial gene markers test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Known colorectal advanced neoplasia group
- description
- Subjects with known colorectal advanced neoplasia and requiring endoscopic resection
- interventionNames
- Diagnostic Test: Bacterial gene markers test
Primary outcomes (2)
- measure
- Serial bacterial gene markers changes (Fn, m3, Bc and Ch) after endoscopic resection of colorectal advanced neoplasia.
- timeFrame
- 6 months
- description
- Bacterial gene markers change tested by quantitative polymerase chain reaction (qPCR)
- measure
- Serial gut microbiome changes after endoscopic resection of colorectal advanced neoplasia.
- timeFrame
- 6 months
- description
- Gut microbiome change tested by metagenomic sequencing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects require endoscopic resection (e.g. endoscopic mucosal resection or endoscopic submucosal dissection) for advanced adenoma or early-stage colorectal cancer; * Aged 18-90 years old; * Written informed consent obtained. Exclusion Criteria: * Absolute contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status); * Contraindications to endoscopic resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets); * Known pregnancy or lactation; * Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
References
Publications (0)
Data not yet available
No reference posted for this study.