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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: 3 L PEG + linaclotide
* Drug: 3 L PEG + placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, inadequate bowel preparation, Boston Bowel Preparation Scale, linaclotide