Status:

RECRUITING

A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers

Lead Sponsor:

Chinese University of Hong Kong

Collaborating Sponsors:

Inner Mongolia People's Hospital

Conditions:

Colorectal Neoplasms

Colorectal Adenoma

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

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-rela...

Detailed Description

Recent evidence has demonstrated the association between altered gut microbiome environment and the progression of colorectal cancer (CRC) from its precancerous lesions. Some pathogenic species of bac...

Eligibility Criteria

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.

Key Trial Info

Start Date :

December 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

649 Patients enrolled

Trial Details

Trial ID

NCT05592886

Start Date

December 15 2022

End Date

December 31 2027

Last Update

August 1 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

2

Prince of Wales Hospital

Hong Kong, Hong Kong