drugset / Trial / NCT05726344

Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

NCT05726344

RandomizedParallel-groupTriple-blindTreatment

Summary

Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study. Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients. Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.

Timeline

Start
2023-02-10
Primary completion
2023-12-13
Completion
2023-12-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactulose Other / unclassified 162.5 g Oral
Subject polyethylene glycol Other / unclassified 180 g Oral
Background Bisacodyl Small molecule 20 mg Oral

Indications

No indication recorded.