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An exploratory clinical trial of the tolerability and effectiveness of TCIC-001 (food) in bowel preparation before colonoscopy

An exploratory clinical trial of the tolerability and effectiveness of TCIC-001 (food) in bowel preparation before colonoscopy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048931
Enrollment
Unknown
Registered
2021-07-19
Start date
2021-07-19
Completion date
Unknown
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group 1:60g TCIC-001 +1500ml water
Group 2:137.12g PEG+2000ml water
Group 3:48g TCIC-001 +1500ml water
Group 4:60g TCIC-001 +1000ml water
Group 5:60g TCIC-001 +2000ml water
Group 6:72g TCIC-001 +1500ml water

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. The subjects' vital signs, physical examinations, laboratory examinations, and other exam results before enrollment are normal or clinical non-significant judged by the investigator; 3. Subjects who intend to be hospitalized for colonoscopy; 4. The subject can communicate well with the researcher, understand and obey the requirements of the experiment, understand and voluntarily sign the informed consent form before performing any research-related operations.

Exclusion criteria

Exclusion criteria: 1. Subjects suspected of intestinal malignancies or intestinal obstruction; 2. Those who have used drugs that are known to cause damage to a certain organ within three months before the test, who have suffered from a serious illness, or have a history of abdominal surgery; 3. Subjects during pregnancy and lactation; 4. The researcher determines that the laboratory inspection does not meet the requirements; 5. The investigator believes that any other circumstances that may affect the subjects' informed consent or follow the test protocol, or the subject's participation in the test may affect the test results or their own safety.

Design outcomes

Primary

MeasureTime frame
Boston bowel preparation scale score;

Countries

China

Contacts

Public ContactZhou Pinghong

Zhongshan Hospital, Fudan University

zhou.pinghong@zs-hospital.sh.cn+86 13681971063

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026