Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2024-04-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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3L PEG + Linaclotide

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

Group Type EXPERIMENTAL

3L PEG + Linaclotide

Intervention Type DRUG

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.

3L PEG alone

Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.

Group Type ACTIVE_COMPARATOR

3L PEG

Intervention Type DRUG

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.

2L PEG + Linaclotide

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

Group Type EXPERIMENTAL

2L PEG + Linaclotide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes