drugset / Trial / NCT03100513

PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

NCT03100513

Phase 4 Unknown 100 enrolled Tanta University
RandomizedParallel-groupOpen-labelTreatment

Summary

The current standard of care for patients with HE includes non-absorbable disaccharides(lactulose);The chemical name for lactulose is 4-O-β-D-galactopyranosyl-D-fructofuranose.The exact mode of action by lactulose is thought to be the conversion to lactic acid and acetic acid by colonic bacteria resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to ammonium (NH4+), which is relatively membrane impermeable; therefore, less ammonia is absorbed by the colon. Gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. Nonabsorbable disaccharides also work as a cathartic, clearing the gut of ammonia before it can be absorbed.

Timeline

Start
2017-03-11
Primary completion
2019-10
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lactulose Other / unclassified 20 g Oral
Comparator Lactulose Other / unclassified 30 g Oral
Comparator Lactulose Other / unclassified 200 g Oral
Comparator polyethylene glycol Other / unclassified 192 g Oral
Comparator polyethylene glycol Other / unclassified 256 g Oral