CBM588 demonstrated potential to reduce colorectal adenoma recurrence in high-risk patients, supporting its role as a feasible, non-invasive preventive strategy.
Key Findings
Results
In per-protocol analysis, CBM588 significantly reduced mean polyp count and adenoma recurrence rate compared to control in the first year.
First-year PP analysis showed the CBM588-first group had a mean polyp count of 0.80 vs. 1.25 in the control-first group (p < 0.05).
Adenoma recurrence rate was 29.76% in the CBM588-first group vs. 44.71% in the control-first group in PP analysis (p < 0.05).
The study was a randomized, single-blind, two-year crossover trial with annual surveillance colonoscopies.
398 participants with a history of adenomatous polyps were enrolled.
Results
In intention-to-treat analysis, CBM588 showed numerically lower polyp counts and recurrence rates but differences did not reach statistical significance.
First-year ITT analysis showed mean polyp count of 0.78 (CBM588-first) vs. 1.00 (control-first), p = 0.10.
Adenoma recurrence rate was 30.00% in the CBM588-first group vs. 35.35% in the control-first group, p = 0.26.
Both ITT and PP analyses were pre-specified outcome approaches in the trial design.
Results
After crossover, the group receiving CBM588 in the second year experienced similar benefits, and by year two both groups had comparable outcomes.
The crossover design allowed each participant to serve as their own control across the two-year period.
No carryover effect was evident after the crossover.
By year two, both groups had comparable adenoma recurrence outcomes regardless of treatment sequence.
Results
The number needed to treat (NNT) to prevent one adenoma recurrence in one year differed substantially between ITT and PP analyses.
NNT was 19 in the ITT analysis.
NNT was 7 in the PP analysis.
These estimates reflect prevention of one adenoma recurrence per year of CBM588 treatment.
Results
CBM588 was well tolerated with no serious adverse events reported during the trial.
The trial was conducted over two years with participants receiving CBM588 for one year and observation for the other year.
No serious adverse events were attributed to CBM588 treatment.
The tolerability profile supports CBM588 as a feasible, non-invasive preventive strategy.
Methods
The study enrolled high-risk patients with a history of adenomatous polyps in a randomized crossover design.
A total of 398 participants were enrolled.
The trial was randomized, single-blind, and two years in duration.
Participants were assigned to receive CBM588 in either the first or second year, with the alternate year as observation.
Annual surveillance colonoscopies were used to assess outcomes.