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Completed

NCT Number: NCT05379491

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningxia Hui Autonomous Region People's Hospital, Yinchuan, Ningxia, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 + 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.

Primary outcomes

  1. Bowel preparation adequate rate

    Time frame: 48 hours

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

  2. Number of adenomas per patient

    Time frame: 48 hours

    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.

Secondary outcomes

  1. Subject willingness to repeat the preparation

    Time frame: 1 Day of colonoscopy

    Survey

  2. Tolerance to bowel preparation

    Time frame: 1 Day of colonoscopy

    It will be subjective and assessed as non, mild, moderate, severe.

  3. Tolerance to colonoscopy

    Time frame: 1 Day of colonoscopy

    It will be subjective and assessed as non, mild, moderate, severe.

  4. Average number of polyps per patient

    Time frame: 1 Day of colonoscopy

    Average number of polyps detected per patient by colonoscopy in each arm

  5. Average number of adenomas per patient

    Time frame: 1 Day of colonoscopy

    Average number of adenomas detected per patient by colonoscopy in each arm

  6. Withdrawal time

    Time frame: 1Day of colonoscopy

    the time from cecal identification to the withdrawal of the colonoscopy across the anus minus the time of polypectomy.

  7. Cecal intubation rate for colonoscopies

    Time frame: 1 Day of colonoscopy

    Cecal intubation was defined as reaching the ileocecal valve

Sponsors and collaborators

Lead sponsor

Zhiguo Liu

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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