Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhiguo Liu
• Treatments: Linaclotide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.