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

Launched by CHINESE UNIVERSITY OF HONG KONG · Oct 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new oral supplement called SMT04 to see if it can help reduce the chances of colorectal adenomas (a type of growth that can lead to cancer) coming back after they have been removed. The trial is designed for adults aged 18 to 90 who have advanced colorectal neoplasia, which means they have abnormal growths in the colon that need to be taken out using a procedure called endoscopic resection. Participants will need to have had a thorough colonoscopy before the procedure to ensure their colon is clear of other issues.

If you or a loved one is eligible, you will be asked to take the SMT04 supplement and will be monitored to see how well it works in preventing the return of these growths and in reducing certain bacteria linked to colorectal cancer. This trial is currently recruiting participants, and those interested will need to provide written consent to join. It’s important to note that people with certain health conditions, such as inflammatory bowel disease or a history of specific types of cancer, cannot participate. This study could potentially lead to better ways to manage and prevent colorectal cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects have advanced colorectal neoplasia requiring endoscopic resection (endoscopic mucosal resection, endoscopic submucosal dissection, etc.);
• • 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);
• • Aged 18-90 years old;
• • Written informed consent obtained
• Exclusion Criteria:
• • Known residual colorectal neoplasia not removed (except hyperplastic polyps);
• • Contraindications to endoscopic resection due to deep submucosal invasion;
• • 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.