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

Zhiguo Liu

Status: Completed

Conditions: Colonoscopy

Treatments: Drug: 3 L PEG + placebo; Drug: 3 L PEG + linaclotide

Study type: Interventional

Funder types: Other

Identifiers

NCT05379491

KY20222119-F-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups, including a placebo group

3 L PEG + Linaclotide

Active Comparator group

Description:

Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide.

Treatment:

Drug: 3 L PEG + linaclotide

3 L PEG + Placebo

Placebo Comparator group

Description:

Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo.

Treatment:

Drug: 3 L PEG + placebo