Status:
COMPLETED
Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
Lead Sponsor:
Zhiguo Liu
Conditions:
Colonoscopy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene gl...
Detailed Description
The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonosc...
Eligibility Criteria
Inclusion
- scheduled for colonoscopy
- age ≥ 18
- meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI \> 25 kg/m2, age \> 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage
- willing to provide informed consent
Exclusion
- unable to cooperate with questionnaires
- uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg)
- pregnancy or lactation
- toxic colitis, or megacolon
- allergy to preparation components
- active inflammatory bowel disease
- clinically significant electrolyte abnormalities
- a history of severe renal, liver, or cardiac insufficiency
- has already been enrolled in the study
- gastrointestinal obstruction
- obvious gastroparesis or gastric retention
- bowel perforation
- polyp syndrome
- history of colectomy
- any other condition that is inappropriate for enrollment as judged by the investigator.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT05379491
Start Date
August 1 2022
End Date
July 15 2023
Last Update
May 23 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Ningxia Hui Autonomous Region People's Hospital
Yinchuan, Ningxia, China, 750002
2
Xi'an Central Hospital
Xi'an, Shaanxi, China, 710004
3
Xi'an Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, China, 710004
4
Air Force 986 Hospital
Xi'an, Shaanxi, China, 710036