Trial · Interventional

Status unknownNot applicableRegistry data

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

NCTNCT05137145Other id2021030

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Not applicable
Enrollment: 300 participants (estimated)
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University · Other
Design: Randomized · Single masking
Countries: 1 country
China
Start: 1 Sept 2021
Primary completion: 31 Mar 2022 (estimated)
Completion: 30 Apr 2022 (estimated)
First posted: 30 Nov 2021
Last update posted: 30 Nov 2021
Conditions: Bowel Preparation

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

N/A
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
NCT05137145
1 Sept 2021 to est. 30 Apr 2022

Registry summary

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

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.

Interventions

LinaclotideDrug
Compound Polyethylene Glycol Electrolyte PowderDrug

Arms4

Experimental
The control group
The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines
Experimental
the observation group 1
the observation group 1 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine
Experimental
the observation group 2
the observation group 2 was given Linaclotide(290 ug) in 1 day combined with 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine
Experimental
the observation group 3
the observation group 3 was given Linaclotide(290 ug) in 3 day combined with 3L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestine.

Primary outcomes1

Outcomes the sponsor listed as primary.

The Boston Bowel Preparation Scale
Time frame · colonoscopy screening procedure
Registry description
the effect of colon cleansing

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2024

3 results

Efficacy of Polyethylene Glycol Electrolyte Powder Combined With Linaclotide for Colon Cleansing in Patients With Chronic Constipation Undergoing Colonoscopy: A Multicenter, Single-Blinded, Randomized Controlled Trial.

Wang et al. 2024Clinical and translational gastroenterologycited by 14

PMID 38713137PMC11196075DOI 10.14309/ctg.0000000000000708PUB-38713137

Free to read · publisher termsCC BY-NC-ND3 results

Read at source See results (3)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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: * Exclusion criteria included: (1)age \<18 or\> 75; (2) severe chronic renal failure, severe congestive heart failure and Liver dysfunction ;(3)with uncontrolled hypertension, diabetes, intestinal obstruction, intestinal perforation and electrolyte disorders, inflammatory intestinal disease and other organic gastrointestinal diseases;(4)with neurologic, endocrine, or metabolic disorders;(5)treatment with other gastrointestinal drivers, laxatives, and antilaxatives within nearly 2 weeks;(6)history of colorectal surgery;(7) dysphagia; (8) compromised swallowing reflex or mental status;(9)with consciousness disorders or examination intolerance;(10)pregnancy or lactation;(11)allergic to the drug composition;(12)Suspected history of alcohol or substance abuse; (13)Recent participants in clinical trials; (14) unable to give informed consent.

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