Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 30, 2022

Interventions

  • 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.
  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: 3L PEG + Linaclotide
    • Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution combined with 3-day linaclotide.
  • Active Comparator: 3L PEG alone
    • Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.
  • Experimental: 2L PEG + Linaclotide
    • Bowel preparation for colonoscopy was performed with 2L polyethylene glycol solution combined with 3-day linaclotide.

Clinical Trial Outcome Measures

Primary Measures

  • Bowel preparation adequate rate
    • Time Frame: within 10 minute after viewing colonoscopy video.
    • The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .

Secondary Measures

  • Boston bowel preparation scale score
    • Time Frame: Within 10 minute after viewing colonoscopy video.
    • 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.
  • Aronchick Scale
    • Time Frame: Within 10 minute after viewing colonoscopy video.
    • 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.
  • Bowel preparation excellent rate
    • Time Frame: Within 10 minute after viewing colonoscopy video.
    • The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
  • Bowel preparation completion rate assessed by questionnaire survey
    • Time Frame: Immediately after questionnaire survey.
    • Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.
  • Subjects satisfaction rate assessed by questionnaire survey
    • Time Frame: Immediately after 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.
  • Endoscopists satisfaction with the quality of bowel preparation
    • Time Frame: Immediately after colonoscopy.
    • 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.
  • Adenoma detection rate
    • Time Frame: 14 days after colonosopy.
    • 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.
  • Polyp detection rate
    • Time Frame: Immediately after colonoscopy.
    • 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.
  • Incidence of adverse events assessed by questionnaire survey
    • Time Frame: Immediately after questionnaire survey.
    • Proportion of subjects with adverse events occuring in intestinal preparation.
  • Drug compliance in linaclotide group
    • Time Frame: Immediately after questionnaire survey.
    • Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Changhai Hospital
  • Collaborator
    • Shanxi Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhaoshen Li, Professor – Changhai Hospital
  • Overall Official(s)
    • Zhaoshen Li, Principal Investigator, Changhai Hospital
  • Overall Contact(s)
    • Zhaoshen Li, M.D., +86-021-31161365, li.zhaoshen@hotmail.com

References

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.

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