Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

Bowel Preparation for Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05291325
• Other study ID #: Linaclotide
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: April 28, 2024

Study information

• Verified date: June 2024
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1607
• Est. completion date: April 28, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital, Naval Medical University	Shanghai

Sponsors (27)

Lead Sponsor

Collaborator

Changhai Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Incidence of adverse events assessed by questionnaire survey	Proportion of subjects with adverse events occuring in intestinal preparation.	Immediately after questionnaire survey.
Secondary	Drug compliance in linaclotide group	Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.	Immediately after questionnaire survey.