Clinical trial NCT05291325: Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy
Official title: Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Preparation for Colonoscopy
Keywords: Linaclotide
Bowel preparation
colonoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Provincial People's Hospital
name: 900 Hospital of Joint Logistics Support Force of PLA
name: Ruijin Hospital
name: The First Affiliated Hospital of Nanchang University
name: Qilu Hospital of Shandong University
name: The Affiliated Hospital of Qingdao University
name: Ruian People's Hospital
name: Affiliated Yueqing Hospital of Wenzhou Medical University
name: The First Affiliated Hospital of Soochow University
name: The 7th Medical Center of the PLA General Hospital
name: The First Hospital of Jilin University
name: The Second Hospital of Hebei Medical University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: Ningxia Medical University General Hospital
name: Affiliated Hospital of Qinghai University
name: Yunnan First People's Hospital
name: Xiangya Second Hospital, Central South University
name: Shanghai Zhongshan Hospital
name: Daping Hospital, Army Military Medical University
name: Zunyi Medical College
name: Huizhou Municipal Central Hospital
name: Affiliated Hospital of Southwest Medical University
name: The First Hospital of Shihezi University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Tangdu Hospital of Air Force Military Medical University
First posted: 2022-03-22
Enrollment: 1607
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bowel preparation adequate rate
timeFrame: within 10 minute after viewing colonoscopy video.
Secondary outcomes:
measure: Boston bowel preparation scale score
timeFrame: Within 10 minute after viewing colonoscopy video.
measure: Aronchick Scale
timeFrame: Within 10 minute after viewing colonoscopy video.
measure: Bowel preparation excellent rate
timeFrame: Within 10 minute after viewing colonoscopy video.
measure: Bowel preparation completion rate assessed by questionnaire survey
timeFrame: Immediately after questionnaire survey.
measure: Subjects satisfaction rate assessed by questionnaire survey
timeFrame: Immediately after questionnaire survey.
measure: Endoscopists satisfaction with the quality of bowel preparation
timeFrame: Immediately after colonoscopy.
measure: Adenoma detection rate
timeFrame: 14 days after colonosopy.
measure: Polyp detection rate
timeFrame: Immediately after colonoscopy.
measure: Incidence of adverse events assessed by questionnaire survey
timeFrame: Immediately after questionnaire survey.
measure: Drug compliance in linaclotide group
timeFrame: Immediately after questionnaire survey.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.