New oral synbiotic formula to reduce colorectal adenoma recurrence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This double-blinded randomized controlled trial evaluates the effectiveness of a novel oral synbiotic formula (SMT04) in preventing the recurrence of adenomas and reducing bacterial gene markers associated with colorectal neoplasia after endoscopic resection. The study is based on the premise that gut microbiome alterations contribute to colorectal cancer progression, and aims to leverage the combined effects of probiotics and prebiotics to restore a healthy microbiota. Participants will receive either the active synbiotic formula or a placebo, and their outcomes will be monitored for signs of adenoma recurrence and changes in bacterial markers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting
• Inner Mongolia People's Hospital
  Hohhot, Inner Mongolia, China Not yet recruiting

Study contacts

• Principal investigator: Louis Lau — Prince of Wales Hospital, Shatin, Hong Kong
• Study coordinator: Louis Lau
• Email: louishslau@cuhk.edu.lhk
• Phone: 35052211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.