RecruitingNot ApplicableNCT05592886

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


Sponsor

Chinese University of Hong Kong

Enrollment

649 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

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-related bacterial gene markers after endoscopic resection of colorectal advanced neoplasia.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a synbiotic supplement (a combination of probiotics and prebiotics) taken by mouth to see if it can reduce the chance of colon polyps coming back after they have been removed. It also measures changes in gut bacteria linked to colorectal cancer risk. **You may be eligible if...** - You are 18–90 years old - You recently had advanced colorectal polyps (adenomas or early-stage cancer) removed via colonoscopy - Your colonoscopy was complete and your bowel was well-prepared - All visible polyps were completely removed **You may NOT be eligible if...** - There are still remaining polyps that were not removed - You have had prior colon surgery - You have a hereditary colorectal cancer syndrome or inflammatory bowel disease - You are pregnant or breastfeeding - You have a weakened immune system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSMT04 formula

The SMT04 formula is a synbiotic containing probiotics and prebiotics

OTHERActive placebo

The active placebo is 2 mg Vitamin C with an inert substance made of starch filler. The flavor, coloring and appearance are unidentifiable to the study product.


Locations(2)

Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China

Prince of Wales Hospital

Hong Kong, Hong Kong

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NCT05592886


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