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

Zhiguo Liu720 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

720

Conditions

Colonoscopy

Interventions

3 L PEG + linaclotideDRUG

Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.

3 L PEG + placeboDRUG

Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (8)

Ningxia Hui Autonomous Region People's Hospital

Yinchuan, Ningxia, China

Xi'an Central Hospital

Xi'an, Shaanxi, China

Xi'an Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, China

Air Force 986 Hospital

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

Bowel preparation adequate rate

The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.

Time frame: 48 hours

Number of adenomas per patient

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.

Time frame: 48 hours