Application of Linaclotide Capsule in Bowel Preparation for Patients at High Risk of Inadequate Bowel Preparation

NCT05379491 | Completed

• 1 other identifier: KY20222119-F-1
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 8

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.

Conditions

Colonoscopy

Keywords

colonoscopy; inadequate bowel preparation; Boston Bowel Preparation Scale; linaclotide

Outcome Measures

Primary Outcomes (2)

• Bowel preparation adequate rate

  The rate of participants with all colon segment scores (proximal colon, transverse colon, distal colon) are ≥ 2 according to Boston Bowel Preparation Scale.

  48 hours

• Number of adenomas per patient

  If there is no significant difference in the first primary outcome between the two groups, compare the average number of adenomas per patient detected by colonoscopy.

  48 hours

Secondary Outcomes (7)

• Subject willingness to repeat the preparation

  1 Day of colonoscopy

• Tolerance to bowel preparation

  1 Day of colonoscopy

• Tolerance to colonoscopy

  1 Day of colonoscopy

• Average number of polyps per patient

  1 Day of colonoscopy

• Average number of adenomas per patient

  1 Day of colonoscopy

Study Arms (2)

3 L PEG + Linaclotide

ACTIVE COMPARATOR

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

Drug: 3 L PEG + linaclotide

3 L PEG + Placebo

PLACEBO COMPARATOR

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

Drug: 3 L PEG + placebo

Interventions

3 L PEG + linaclotide DRUG

Participants take a linaclotide capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another linaclotide capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.

3 L PEG + Linaclotide

3 L PEG + placebo DRUG

Participants take a placebo capsule on the day before colonoscopy at least 30 minutes before the first meal (if this is impossible, take the capsule as early as possible on that day). Participants take 1 L polyethylene glycol electrolyte solution within 1 hour from 8 p.m the night before the examination and take another placebo capsule and 2 L polyethylene glycol electrolyte solution 4 hours before the colonoscopy.

3 L PEG + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhiguo Liu: lead

Study Sites (8)

Ningxia Hui Autonomous Region People's Hospital

Yinchuan, Ningxia, 750002, China

Location

Xi'an Central Hospital

Xi'an, Shaanxi, 710004, China

Location

Xi'an Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, 710004, China

Location

Air Force 986 Hospital

Xi'an, Shaanxi, 710036, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710036, China

Location

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710068, China

Location

Linfen Central Hospital

Linfen, Shanxi, 041000, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

MeSH Terms

Interventions

linaclotide

Study Officials

• Zhiguo Liu, M.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomized grouping sequence by block randomization with a block size of 4 is generated using a web-based service. Linaclotide or placebo is allocated according to the sequence and labelled in numerial order (1 - 720) without labelling the allocation information. Therefore, patients, endoscopists, and other investigators at each center will be unaware of the drug allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 18, 2022
• Study Start: August 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)