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

An Efficacy and Safety Evaluation of Linaclotide in Bowel Preparation by Patients at High Risk of Inadequate Bowel Preparation: a Multicenter, Randomized, Double-Blind, Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: 3 L PEG + linaclotide; Drug: 3 L PEG + placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiguo Liu, M.D; Phone Number: 86-29-84771535; Email: liuzhiguo@fmmu.edu.cn
• Study Contact Backup: Name: Xiaotong Fan, M.E; Phone Number: +8618792656903; Email: lich_puck@163.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750002
      • Ningxia Hui Autonomous Region People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Shaanxi Provincial People's Hospital
    • Xi'an, Shaanxi, China, 710004
      • Xi'an Central Hospital
    • Xi'an, Shaanxi, China, 710004
      • Xi'an Jiaotong University Second Affiliated Hospital
    • Xi'an, Shaanxi, China, 710036
      • Air Force 986 Hospital
    • Xi'an, Shaanxi, China, 710036
      • Xijing Hospital of Digestive Diseases
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Linfen Central Hospital
    • Taiyuan, Shanxi, China
      • The Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3 L PEG + Linaclotide; Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day linaclotide.	Drug: 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.
Placebo Comparator: 3 L PEG + Placebo; Bowel preparation for colonoscopy was performed with 3 L polyethylene glycol solution combined with 2-day placebo.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject willingness to repeat the preparation	Survey	1 Day of colonoscopy
Tolerance to bowel preparation	It will be subjective and assessed as non, mild, moderate, severe.	1 Day of colonoscopy
Tolerance to colonoscopy	It will be subjective and assessed as non, mild, moderate, severe.	1 Day of colonoscopy
Average number of polyps per patient	Average number of polyps detected per patient by colonoscopy in each arm	1 Day of colonoscopy
Average number of adenomas per patient	Average number of adenomas detected per patient by colonoscopy in each arm	1 Day of colonoscopy
Withdrawal time	the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy.	1Day of colonoscopy
Cecal intubation rate for colonoscopies	Cecal intubation was defined as reaching the ileocecal valve	1 Day of colonoscopy

Collaborators and Investigators

• Sponsor: Zhiguo Liu
• Investigators: Principal Investigator: Zhiguo Liu, M.D., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: May 14, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; inadequate bowel preparation; Boston Bowel Preparation Scale; linaclotide
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Linaclotide
• Other Study ID Numbers: KY20222119-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No