Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patient… (NCT05137145) | Clinical Trial Compass
UnknownNot Applicable
Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation
China300 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
The Boston Bowel Preparation Scale
Timeframe: colonoscopy screening procedure
Trial details
NCT IDNCT05137145
SponsorSecond Affiliated Hospital of Xi'an Jiaotong University