Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study

The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.

Study Overview

• Status: Completed
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Drug: 3L PEG + Linaclotide; Drug: 3L PEG; Drug: 2L PEG + Linaclotide

• Study Type: Interventional
• Enrollment (Actual): 1607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital, Naval Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18-75 years old, male or female;
• To undergo diagnostic, screening or monitoring colonoscopy;
• Signed written informed consent;

Exclusion Criteria:

• Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
• History of abdominal or pelvic surgery;
• Pregnant and lactating women;
• BMI > 28, BMI < 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
• Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
• Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
• Colon polyps have been identified;
• Stow score 7 (watery, no solid mass), diarrhea was considered;
• Participation in other interventional clinical trials within 60 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3L PEG + Linaclotide; Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide.	Drug: 3L PEG + Linaclotide; Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
Active Comparator: 3L PEG alone; Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.	Drug: 3L PEG; Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
Experimental: 2L PEG + Linaclotide; Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide.	Drug: 2L PEG + Linaclotide; Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation adequate rate	The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .	within 10 minute after viewing colonoscopy video.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston bowel preparation scale score	The BBPS scoring rules: 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid; 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation. 3 intestinal segments were scored separately: the right side of the colon, the transverse section of the colon, and the left side of the colon. Total BBPS score 0-9, the higher the score, the better the quality of bowel preparation.	Within 10 minute after viewing colonoscopy video.
Aronchick Scale	Overall bowel preparation was scored prior to irrigation or suction. The Aronchick Scale scoring rules: 1, excellent, a small amount of liquid, 95% mucous membrane is visible; 2, good, plenty of clear fluid, covering 5%-25% of mucous membrane, 90% mucous membrane is visible; 3, medium, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 4, poor, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 5, inadequate, repeated bowel preparation or reexamination is required. Total Aronchick score 1-5, the lower the score, the better the quality of bowel preparation.	Within 10 minute after viewing colonoscopy video.
Bowel preparation excellent rate	The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.	Within 10 minute after viewing colonoscopy video.
Bowel preparation completion rate assessed by questionnaire survey	Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.	Immediately after questionnaire survey.
Subjects satisfaction rate assessed by questionnaire survey	Proportion of subjects satisfacted with the whole intestinal preparation process. Subjects satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.	Immediately after questionnaire survey.
Endoscopists satisfaction with the quality of bowel preparation	Proportion of endoscopists satisfacted with the quality of bowel preparation during colonoscopy. Endoscopists satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.	Immediately after colonoscopy.
Adenoma detection rate	The adenoma detection rate was calculated as the number of colonoscopies with at least one adenoma detected divided by the total number of colonoscopies in the group. Adenomatous polyps must be confirmed by pathological findings.	14 days after colonosopy.
Polyp detection rate	The polyp detection rate was calculated as the number of colonoscopies with at least one polyp detected divided by the total number of colonoscopies in the group.	Immediately after colonoscopy.
Incidence of adverse events assessed by questionnaire survey	Proportion of subjects with adverse events occuring in intestinal preparation.	Immediately after questionnaire survey.
Drug compliance in linaclotide group	Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.	Immediately after questionnaire survey.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; The Second Hospital of Hebei Medical University; Qilu Hospital of Shandong University; The Affiliated Hospital of Qingdao University; Ruijin Hospital; The First Affiliated Hospital of Soochow University; The First Hospital of Jilin University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Huizhou Municipal Central Hospital; The Second Affiliated Hospital of Dalian Medical University; Affiliated Hospital of Qinghai University; Zunyi Medical College; Affiliated Hospital of Southwest Medical University; Shanxi Provincial People's Hospital; The 900th Hospital of the PLA; Ruian People's Hospital; Yueqing People's Hospital; The 7th Medical Center of the PLA General Hospital; Affiliated Hospital of Inner Mongolia Medical University; Ningxia Medical University General Hospital; Yunnan First People's Hospital; Xiangya Second Hospital, Central South University; Zhongnan Hospital Affiliated to Wuhan University; Daping Hospital, Army Military Medical University; The First Hospital of Shihezi University; Tangdu Hospital of Air Force Military Medical University
• Investigators: Principal Investigator: Zhaoshen Li, Changhai Hospital

Publications and helpful links

General Publications

• Zhang M, Zou W, Xu C, Jia R, Liu K, Xu Q, Xu H. Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e625-e633. doi: 10.1097/MEG.0000000000002184.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): April 28, 2024

Study Registration Dates

• First Submitted: March 18, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; Bowel preparation; Linaclotide
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Linaclotide
• Other Study ID Numbers: Linaclotide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No