Evaluation of efficacy and tolerability of TCIC-001 for bowel preparation prior to colonoscopy: an exploratory randomized controlled clinical trial
10.12025/j.issn.1008-6358.2025.20250401
- VernacularTitle:TCIC-001用于结肠镜前肠道准备的有效性和耐受性：一项探索性随机对照临床试验
- Author:
Baohui SONG
1
;
Xiaolong ZHUANG
2
;
BAHETINUER JIASHAER
1
;
Xiaoyue XU
1
;
Jiaxin XU
1
;
Danfeng ZHANG
1
;
Yunshi ZHONG
1
;
Pinghong ZHOU
1
;
Mingyan CAI
1
Author Information
1. Endoscopy Center, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
2. Endoscopy Center, Shanghai Jiangong Hospital, Shanghai 200083, China.
- Publication Type:Monographicreport:Endoscopicdiagnosisandtreatmentofdigestivesystemdiseases
- Keywords:
TCIC-001;
bowel preparation;
colonoscopy;
tolerability;
efficacy;
safety
- From:
Chinese Journal of Clinical Medicine
2025;32(5):743-747
- CountryChina
- Language:Chinese
-
Abstract:
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 Prospective inclusion of 62 patients who were scheduled to undergo colonoscopy at Zhongshan Hospital, Fudan University from July 2021 to July 2022. They were randomly divided into TCIC-001 group (n=31) and PEG group (n=31) using a random number table method. The TCIC-001 group took TCIC-001 orally, drinking water in stages, with a total liquid intake of 1 500 mL; the PEG group took PEG orally, taking it in 4 doses, with a total liquid intake of 3 000 mL. The primary endpoint indicator is the quality of intestinal hygiene evaluated by the Boston Bowel Preparation Scale (BBPS), the secondary endpoint indicators were medication adherence, medication duration, frequency of bowel movements, duration of bowel movements, and incidence of adverse events between two groups. Results No significant differences were observed in sex, age, or defecation frequency between the two groups. 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. For tolerability, the TCIC-001 group had a shorter medication duration compared to the PEG group ([48.8±25.9] min vs [82.8±28.4] min, P<0.001), a longer defecation duration ([288.6±74.0] min vs [236.5±74.3] min, P<0.001), and a lower incidence of first defecation before medication completion (9.68% vs 41.94%, P=0.004). 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%), and no other adverse events. 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.
