Clinical trial NCT05379491: Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation
Official title: An Efficacy and Safety Evaluation of Linaclotide in Bowel Preparation by Patients at High Risk of Inadequate Bowel Preparation: a Multicenter, Randomized, Double-Blind, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
inadequate bowel preparation
Boston Bowel Preparation Scale
linaclotide
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the colon cleansing quality of linaclotide versus control in adult patients at high risk of inadequate bowel preparation: one group will receive polyethylene glycol solution (PEG) split dose (1 L + 2 L) plus linaclotide and the other group PEG (1 L + 2 L) plus placebo before colonoscopy.

Detailed description: The objective of this trial is to compare the colon cleanliness achieved with PEG split dose (1 L + 2 L) + linaclotide versus PEG split dose (1 L + 2 L) + placebo for patients scheduled for a colonoscopy at high risk of inadequate bowel preparation. The target patients are those with constipation, poor bowel preparation history, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), BMI \> 25 kg/m2, age \> 70, tricyclic antidepressants usage, or opioid usage, as defined by the latest version of Bowel Preparation Guidelines.

Eligibility criteria: Inclusion Criteria:

* scheduled for colonoscopy
* age ≥ 18
* meet any of the followings: functional constipation according to Rome IV criteria, poor bowel preparation history, BMI \> 25 kg/m2, age \> 70, history of abdominal/pelvic surgery, comorbidity (diabetes, Parkinson's disease, stroke, or history of spinal cord injury), antidepressant usage, opioid usage
* willing to provide informed consent

Exclusion Criteria:

* unable to cooperate with questionnaires
* uncontrolled hypertension (systolic .170 mm Hg and diastolic.100mmHg)
* pregnancy or lactation
* toxic colitis, or megacolon
* allergy to preparation components
* active inflammatory bowel disease
* clinically significant electrolyte abnormalities
* a history of severe renal, liver, or cardiac insufficiency
* has already been enrolled in the study
* gastrointestinal obstruction
* obvious gastroparesis or gastric retention
* bowel perforation
* polyp syndrome
* history of colectomy
* any other condition that is inappropriate for enrollment as judged by the investigator.

Primary outcomes:
measure: Bowel preparation adequate rate
timeFrame: 48 hours
measure: Number of adenomas per patient
timeFrame: 48 hours
Secondary outcomes:
measure: Subject willingness to repeat the preparation
timeFrame: 1 Day of colonoscopy
measure: Tolerance to bowel preparation
timeFrame: 1 Day of colonoscopy
measure: Tolerance to colonoscopy
timeFrame: 1 Day of colonoscopy
measure: Average number of polyps per patient
timeFrame: 1 Day of colonoscopy
measure: Average number of adenomas per patient
timeFrame: 1 Day of colonoscopy
measure: Withdrawal time
timeFrame: 1Day of colonoscopy
measure: Cecal intubation rate for colonoscopies
timeFrame: 1 Day of colonoscopy
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: Ningxia Hui Autonomous Region People's Hospital
state: Ningxia
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xi'an Jiaotong University Second Affiliated Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Air Force 986 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Linfen
country: China
facility: Linfen Central Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Study Principal Investigator
name: Zhiguo Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: