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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Preparation
• Intervention / Treatment: Drug: Compound Polyethylene Glycol Electrolyte Powder; Drug: Linaclotide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Dai, MD; Phone Number: 13772151298; Email: daifei68@hotmail.com
• Study Contact Backup: Name: wang lianli; Phone Number: 15737939767; Email: 15737939767@163.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Fei Dai, MD; Phone Number: 13772151298; Email: daifei68@hotmail.com
      • Contact: lianli wang; Phone Number: 15737939767; Email: 15737939767@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The control group; The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines	Drug: Compound Polyethylene Glycol Electrolyte Powder; The control group was given 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	Drug: Compound Polyethylene Glycol Electrolyte Powder; The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,; Drug: Linaclotide; 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.
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	Drug: Compound Polyethylene Glycol Electrolyte Powder; The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,; Drug: Linaclotide; 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.
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.	Drug: Compound Polyethylene Glycol Electrolyte Powder; The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,; Drug: Linaclotide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Boston Bowel Preparation Scale	the effect of colon cleansing	colonoscopy screening procedure

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Constipation; Colonoscopy; Linaclotide
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Linaclotide
• Other Study ID Numbers: 2021030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No