NCT05291325

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,607

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2024

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

March 18, 2022

Last Update Submit

June 18, 2024

Conditions

Bowel Preparation for Colonoscopy

Keywords

LinaclotideBowel preparationcolonoscopy

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation adequate rate

    The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .

    within 10 minute after viewing colonoscopy video.

Secondary Outcomes (10)

  • Boston bowel preparation scale score

    Within 10 minute after viewing colonoscopy video.

  • Aronchick Scale

    Within 10 minute after viewing colonoscopy video.

  • Bowel preparation excellent rate

    Within 10 minute after viewing colonoscopy video.

  • Bowel preparation completion rate assessed by questionnaire survey

    Immediately after questionnaire survey.

  • Subjects satisfaction rate assessed by questionnaire survey

    Immediately after questionnaire survey.

  • +5 more secondary outcomes

Study Arms (3)

3L PEG + Linaclotide

EXPERIMENTAL

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

Drug: 3L PEG + Linaclotide

3L PEG alone

ACTIVE COMPARATOR

Bowel preparation for colonoscopy was performed with 3L polyethylene glycol solution without linaclotide.

Drug: 3L PEG

2L PEG + Linaclotide

EXPERIMENTAL

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

Drug: 2L PEG + Linaclotide

Interventions

3L PEG + LinaclotideDRUG

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.

3L PEG + Linaclotide
3L PEGDRUG

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.

3L PEG alone
2L PEG + LinaclotideDRUG

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.

2L PEG + Linaclotide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old, male or female;
  • To undergo diagnostic, screening or monitoring colonoscopy;
  • Signed written informed consent;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Naval Medical University

Shanghai, 200433, China

Location

Related Publications (2)

  • 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.

    PMID: 34034273BACKGROUND

  • Pan P, Chen H, Wang T, Liu K, Tuo B, Wang R, Fu H, Jiang C, Chen L, Zhao Q, Wang W, Chen W, Guo Q, Chen W, Li Y, Tian Z, Feng Z, Yang S, Fan Y, Luan F, Chen Y, Li Z, Bai Y. Effect of 3-Day Linaclotide Administration to Reduce the Polyethylene Glycol Volume for Colonoscopy Bowel Preparation: A Multicenter, Noninferiority, Randomized Controlled Trial. Am J Gastroenterol. 2025 May 27. doi: 10.14309/ajg.0000000000003557. Online ahead of print.

    PMID: 40423516DERIVED

MeSH Terms

Interventions

linaclotide

Study Officials

  • Zhaoshen Li

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 22, 2022

Study Start

May 25, 2022

Primary Completion

August 30, 2023

Study Completion

April 28, 2024

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations

CN(1)