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NCT05592886Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
649 (estimated)
First submitted
17 Oct 2022
Start date
15 Dec 2022
Primary completion date
15 Dec 2027
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT05592886

What you commit to

  • Study type: Interventional
  • Planned participants: 649
  • From 15 Dec 2022 to the primary completion date, 15 Dec 2027
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to endoscopic resection due to deep submucosal invasion (stage T1b or above);
  • Prior surgical resection of colon;
  • 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);

Other illness

  • Personal history of hereditary polyposis syndrome or inflammatory bowel disease;
  • Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);

Other

  • Known residual colorectal neoplasia not removed (except hyperplastic polyps);
  • Known pregnancy or lactation;
  • Refusal to undergo surveillance colonoscopy.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Inner Mongolia People's Hospital
Coordinator of this site? Confirm its status
HohhotChinaNot yet recruiting
Prince of Wales Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.