Objective To compare the efficacy and tolerability of the novel bowel-cleansing agent TCIC-001 and the traditional polyethylene glycol (PEG) regimen for bowel preparation prior to colonoscopy.

Methods A total of 62 patients scheduled for colonoscopy at Zhongshan Hospital, Fudan University, between July 2021 and July 2022 were prospectively selected and randomized divided into 2 groups. The experimental group (TCIC-001 group, n＝31) received TCIC-001 (drinked in 2 stages, total fluid intake 1 500 mL), while the control group (PEG group, n＝31) received PEG electrolyte powder (administered in 4 doses, total fluid intake 3 000 mL). The primary endpoint was bowel cleanliness assessed by the Boston Bowel Preparation Scale (BBPS). Secondary endpoints included medication compliance, duration of medication completion, defecation frequency, duration of defecation, and adverse events (such as electrolyte disturbances).

Results No significant differences were observed in sex, age, or defecation frequency between the two groups (P＞0.05). For efficacy, both groups achieved equivalent bowel cleanliness, with a “good preparation” rate of 93.55% and comparable BBPS score of each intestinal segment and total scores (P＞0.05). For tolerability, the TCIC-001 group exhibited significantly shorter medication completion time (48.8±25.9 min vs 82.8±28.4 min, P＜0.001) and a lower rate of first defecation before completing medication (9.68% vs 41.94%, P＝0.004) than the PEG group. Regarding safety, no significant differences were observed between the TCIC-001 group and the PEG group in incidences of chloride disturbances (0% vs 9.68%) and calcium disturbances (3.23% vs 6.45%). No other adverse events were observed.

Conclusions TCIC-001 demonstrated comparable bowel-cleansing efficacy to PEG while significantly improving tolerability (reduced medication time and lower risk of premature defecation) and maintaining favorable safety.