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Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing Before Colonoscopy in Patients With Chronic Constipation:an Endoscopist-blinded,Randomized,Controlled, Multicentre Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05137145
Enrollment
300
Registered
2021-11-30
Start date
2021-09-01
Completion date
2022-04-30
Last updated
2021-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation

Keywords

Chronic Constipation, Colonoscopy, Linaclotide

Brief summary

Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.

Detailed description

Colonoscopy is an important method to screen, diagnose and treat colon lesions. The quality of bowel preparation is requisite for the accuracy of diagnosis and safety of treatment. To explore the application effect and safety of Linaclotide combined with Compound Polyethylene Glycol Electrolyte Powder on colon cleansing before colonoscopy in patients with chronic constipation. A prospective mult-centers, colonoscopist-blinded study was conducted. A total of 300 patients with constipation who underwent colonoscopy in 8 hospitals from July to December 2021 were selected as study subjects and divided into the control group, observation group 1, observation group 2 and observation group 3 by random number table method, with 75 cases in each group. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.

Interventions

DRUGLinaclotide

The observation group 1 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine, and the observation group 2 was given Linaclotide in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. observation group 3 was given Linaclotide in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine. Intestinal cleanliness and the incidence of adverse reactions of patients in each group were compared.

DRUGCompound Polyethylene Glycol Electrolyte Powder

The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Inclusion criteria included: The inclusion criteria were patients ≥18 years old suffering from≥2 of the following criteria of chronic constipation under the Rome IV standard: straining, hard stool, residual stool feeling, occlusion feeling, manual bowel movement(BM) performed ≥25% of overall BMs, and BM frequency\<3 times a week . A chronic status was defined as symptoms being present for at least six months, with the symptoms described above being present for at least three months.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
The Boston Bowel Preparation Scalecolonoscopy screening procedurethe effect of colon cleansing

Countries

China

Contacts

Primary Contactfei dai, MD
daifei68@hotmail.com13772151298
Backup Contactwang lianli
15737939767@163.com15737939767

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026