Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
- Conditions
- Colonoscopy
- Interventions
- Drug: 3 L PEG + placebo
- Registration Number
- NCT05379491
- Lead Sponsor
- Zhiguo Liu
- 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 glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.
- 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 colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI \> 25 kg/m2, age \> 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 720
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 L PEG + Placebo 3 L PEG + placebo Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo. 3 L PEG + Linaclotide 3 L PEG + linaclotide Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide.
- Primary Outcome Measures
Name Time Method Bowel preparation adequate rate 48 hours The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.
Number of adenomas per patient 48 hours If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy.
- Secondary Outcome Measures
Name Time Method Tolerance to bowel preparation 1 Day of colonoscopy It will be subjective and assessed as non, mild, moderate, severe.
Tolerance to colonoscopy 1 Day of colonoscopy It will be subjective and assessed as non, mild, moderate, severe.
Subject willingness to repeat the preparation 1 Day of colonoscopy Survey
Average number of polyps per patient 1 Day of colonoscopy Average number of polyps detected per patient by colonoscopy in each arm
Average number of adenomas per patient 1 Day of colonoscopy Average number of adenomas detected per patient by colonoscopy in each arm
Withdrawal time 1Day of colonoscopy the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy.
Cecal intubation rate for colonoscopies 1 Day of colonoscopy Cecal intubation was defined as reaching the ileocecal valve
Trial Locations
- Locations (8)
Ningxia Hui Autonomous Region People's Hospital
🇨🇳Yinchuan, Ningxia, China
Xi'an Jiaotong University Second Affiliated Hospital
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
Linfen Central Hospital
🇨🇳Linfen, Shanxi, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China
Xi'an Central Hospital
🇨🇳Xi'an, Shaanxi, China
Air Force 986 Hospital
🇨🇳Xi'an, Shaanxi, China