Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

Naval Military Medical University

Status: Completed

Conditions: Bowel Preparation for Colonoscopy

Treatments: Drug: 3L PEG; Drug: 2L PEG + Linaclotide; Drug: 3L PEG + Linaclotide

Study type: Interventional

Funder types: Other

Identifiers

NCT05291325

Linaclotide

Details and patient eligibility

About

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.

Enrollment: 1,607 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,607 participants in 3 patient groups

3L PEG + Linaclotide

Experimental group

Description:

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

Treatment:

Drug: 3L PEG + Linaclotide

3L PEG alone

Active Comparator group

Description:

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

Treatment:

Drug: 3L PEG

2L PEG + Linaclotide

Experimental group

Description:

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

Treatment:

Drug: 2L PEG + Linaclotide