Clinical trial · Interventional
A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
A Multicenter, Double Blinded Randomized Controlled Trial of a Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
NCT05592886CI-TRIAL-00092987recruitingN/AClinicalTrials.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)
This multicenter, double blinded randomized controlled trial aims to assess the efficacy of a novel oral synbiotic formula (SMT04) in reducing advanced adenoma recurrence and colorectal neoplasia-related bacterial gene markers after endoscopic resection of colorectal advanced neoplasia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Adenoma | Adenoma | CURATED_BROADER | 0.78 |
| 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active placebo | Other | — | UNRESOLVED |
| SMT04 formula | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Receive SMT04 formula
- interventionNames
- Other: SMT04 formula
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- description
- Receive active placebo
- interventionNames
- Other: Active placebo
Primary outcomes (1)
- measure
- The incidence of metachronous recurrent advanced colorectal neoplasia at year 1 (local or at other sites).
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects who have advanced colorectal neoplasia\* removed and confirmed by histopathology; * They have received high quality colonoscopies before or during endoscopic resection (defined as a full colonoscopy with successful caecal intubation, and a Boston Bowel Preparation Scale ≧2 in each colonic segment) with no residual colorectal neoplasia; * Aged 18-90 years old; * Written informed consent obtained * An advanced colorectal neoplasia is defined as an advanced adenoma, sessile serrated lesion or non-invasive colorectal cancer (stage Tis or T1a). Advanced adenoma is defined as an adenoma larger than 10mm, and/or with villous component ≥20%, and/or harboring high grade dysplasia. Exclusion Criteria: * Known residual colorectal neoplasia not removed (except hyperplastic polyps); * Contraindications to endoscopic resection due to deep submucosal invasion (stage T1b or above); * Prior surgical resection of colon; * Personal history of hereditary polyposis syndrome or inflammatory bowel disease; * Known pregnancy or lactation; * Immunocompromised status (e.g. on immunosuppressants (except 5-aminosalicylic acid or short term use of corticosteroids \<4 weeks), on chemotherapy, bone marrow or solid organ transplant, human immunodeficiency virus, congenital immune deficiency); * Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above); * Refusal to undergo surveillance colonoscopy.
References
Publications (0)
Data not yet available
No reference posted for this study.