Study of a New Oral Synbiotic Formula to Lower Advanced Adenoma Recurrence and Related Bacterial Markers After Colorectal Neoplasia Removal

What this Trial Is About

Researchers are evaluating a new oral synbiotic formula called SMT04 to see if it can reduce the recurrence of advanced adenomas and related bacterial gene markers in people who have had colorectal advanced neoplasia removed. The study is a multicenter, double-blinded randomized controlled trial focused on colorectal cancer and its precancerous lesions, exploring how gut microbiome changes may influence disease progression and recurrence. The trial seeks to understand if SMT04 can sustain long-term benefits in lowering harmful bacterial markers linked to colorectal neoplasia. Participants will be randomly assigned to receive either the SMT04 synbiotic formula, which combines probiotics and heat-resistant prebiotics, or an active placebo containing a small amount of vitamin C and inert starch filler with matching appearance and flavor. The trial includes a control group receiving the placebo to compare effects. The SMT04 formula has previously been shown to increase beneficial Bifidobacterium species and reduce certain bacterial gene markers over weeks 2 to 12, but its long-term impact is still being studied. During the year-long study, participants will undergo monitoring to detect any recurrence of advanced colorectal neoplasia through colonoscopies and bacterial gene marker measurements. Researchers will track the incidence and number of recurrent adenomas and advanced neoplasia, as well as changes in bacterial gene markers and their correlation with disease recurrence. The primary outcome is the incidence of recurrent advanced colorectal neoplasia at one year. The study involves regular assessments, including colonoscopy quality checks and histopathological confirmation, to ensure thorough evaluation of treatment effects.

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