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

NCT ID: NCT05379491

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 720 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-07-15

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

3 L PEG + Linaclotide

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

Group Type: ACTIVE_COMPARATOR

3 L PEG + linaclotide

Intervention Type: DRUG

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 + Placebo

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

Group Type: PLACEBO_COMPARATOR

3 L PEG + placebo

Intervention Type: DRUG

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.

Interventions

3 L PEG + linaclotide

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.

Intervention Type: DRUG

3 L PEG + placebo

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhiguo Liu

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhiguo Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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

Xijing Hospital of Digestive Diseases

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

Countries

China

Other Identifiers

KY20222119-F-1

Identifier Type: -

Identifier Source: org_study_id