Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

NCTNCT05291325 (opens ClinicalTrials.gov in a new tab)Other idLinaclotide
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
1,607 participants (actual)
Sponsor
Changhai Hospital · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
25 May 2022
Primary completion
30 Aug 2023
Completion
28 Apr 2024
First posted
22 Mar 2022
Last update posted
20 Jun 2024
Conditions
Bowel Preparation for Colonoscopy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. N/A

    Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

    NCT05291325

    25 May 2022 to 28 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • 3L PEG + LinaclotideDrug
  • 3L PEGDrug
  • 2L PEG + LinaclotideDrug

Arms3

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bowel preparation adequate rate

    Time frame · within 10 minute after viewing colonoscopy video.

    Registry description

    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 outcomes(10)

  1. Boston bowel preparation scale score

    Time frame · Within 10 minute after viewing colonoscopy video.

    Registry description

    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.

  2. Aronchick Scale

    Time frame · Within 10 minute after viewing colonoscopy video.

    Registry description

    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.

  3. Bowel preparation excellent rate

    Time frame · Within 10 minute after viewing colonoscopy video.

    Registry description

    The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.

  4. Bowel preparation completion rate assessed by questionnaire survey

    Time frame · Immediately after questionnaire survey.

    Registry description

    Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.

  5. Subjects satisfaction rate assessed by questionnaire survey

    Time frame · Immediately after questionnaire survey.

    Registry description

    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.

  6. Endoscopists satisfaction with the quality of bowel preparation

    Time frame · Immediately after colonoscopy.

    Registry description

    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.

  7. Adenoma detection rate

    Time frame · 14 days after colonosopy.

    Registry description

    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.

  8. Polyp detection rate

    Time frame · Immediately after colonoscopy.

    Registry description

    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.

  9. Incidence of adverse events assessed by questionnaire survey

    Time frame · Immediately after questionnaire survey.

    Registry description

    Proportion of subjects with adverse events occuring in intestinal preparation.

  10. Drug compliance in linaclotide group

    Time frame · Immediately after questionnaire survey.

    Registry description

    Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial.

Pan et al. 2026The American journal of gastroenterologycited by 1

PMID 40423516PMC12854379DOI 10.14309/ajg.0000000000003557PUB-40423516

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 2021

3 results

Polyethylene glycol combined with linaclotide is an effective and well-tolerated bowel preparation regimen for colonoscopy: an endoscopist-blinded, randomized, controlled trial.

Zhang et al. 2021European journal of gastroenterology & hepatologycited by 24

PMID 34034273DOI 10.1097/meg.0000000000002184PUB-34034273

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.