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

Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03100513

Enrollment

100

Registered

2017-04-04

Start date

2017-03-11

Completion date

2019-12-31

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Brief 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.

Detailed description

Polyethylene glycol electrolyte solution (PEG) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. It is used safely to clean the bowel before colonoscopy.

Interventions

DRUGLactulose

(lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate

DRUGPolyethylene Glycol

PEG as single dose of (3sachets if patient \<75Kg over 3 hours or 4 sachets if patient \>75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Adult Patients with Overt Hepatic Encephalopathy.

Exclusion criteria

1. Patients with active GIT bleeding. 2. Patients with history of bowel obstruction, perforation. 3. Patients with history of allergy to PEG. 4. Treatment with rifaximin or neomycin in the previous 7 days. 5. Patients with major psychiatric illness. 6. Patients receiving benzodiazepines and narcotics. 7. Patients with compromised renal. 8. Patients receiving medications highly bound to plasma proteins eg. Warfarin. 9. Pregnant or lactating women. 10. Fulminant hepatic failure.

Design outcomes

Primary

Measure	Time frame	Description
1 or more in HE grade improvement at 24 hours	24 hours	HE grade improvement at 24 hours

Secondary

Measure	Time frame	Description
Time to HE resolution	2 weeks	Time to Hepatic encephalopathy resolution
Overall length of stay	2 weeks	Overall length of stay

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, MD

Sheriefabdelsalam@yahoo.com00201095159522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026