Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
NCT ID: NCT05137145
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-09-01
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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The control group
The control group was given 4L of Compound Polyethylene Glycol Electrolyte Powder to clear the intestines
Compound Polyethylene Glycol Electrolyte Powder
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
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
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.
Compound Polyethylene Glycol Electrolyte Powder
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
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
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.
Compound Polyethylene Glycol Electrolyte Powder
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
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.
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.
Compound Polyethylene Glycol Electrolyte Powder
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
Interventions
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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.
Compound Polyethylene Glycol Electrolyte Powder
The control group was given Compound Polyethylene Glycol Electrolyte Powder to clear the intestines,
Eligibility Criteria
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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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Responsible Party
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Locations
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The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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Fei Dai, MD
Role: primary
lianli wang
Role: backup
References
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Wang L, Zhang Y, Li J, Ran Y, Wang X, Ma X, Yang Q, Wang F, Hu J, Zhuang K, Wang J, Quan X, Wang S, Meng R, Chen Y, Li X, Song Y, Han S, Hu H, Li L, Dai F. 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. Clin Transl Gastroenterol. 2024 Jun 1;15(6):e1. doi: 10.14309/ctg.0000000000000708.
Other Identifiers
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2021030
Identifier Type: -
Identifier Source: org_study_id