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

Primary Purpose

Bowel Preparation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Linaclotide
Compound Polyethylene Glycol Electrolyte Powder
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bowel Preparation focused on measuring Chronic Constipation, Colonoscopy, Linaclotide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The second affiliated hospital of xi'an jiaotong universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

The control group

the observation group 1

the observation group 2

the observation group 3

Arm Description

The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines

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

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

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.

Outcomes

Primary Outcome Measures

The Boston Bowel Preparation Scale
the effect of colon cleansing

Secondary Outcome Measures

Full Information

First Posted
November 16, 2021
Last Updated
November 29, 2021
Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05137145
Brief Title
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation
Keywords
Chronic Constipation, Colonoscopy, Linaclotide

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
Experimental
Arm Description
The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines
Arm Title
the observation group 1
Arm Type
Experimental
Arm Description
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
Arm Title
the observation group 2
Arm Type
Experimental
Arm Description
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
Arm Title
the observation group 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Linaclotide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Compound Polyethylene Glycol Electrolyte Powder
Intervention Description
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
Primary Outcome Measure Information:
Title
The Boston Bowel Preparation Scale
Description
the effect of colon cleansing
Time Frame
colonoscopy screening procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fei dai, MD
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
wang lianli
Phone
15737939767
Email
15737939767@163.com
Facility Information:
Facility Name
The second affiliated hospital of xi'an jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Dai, MD
Phone
13772151298
Email
daifei68@hotmail.com
First Name & Middle Initial & Last Name & Degree
lianli wang
Phone
15737939767
Email
15737939767@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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