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

Sherief Abd-Elsalam

Status and phase: Unknown; Phase 4

Conditions: Hepatic Encephalopathy

Treatments: Drug: Lactulose; Drug: Polyethylene Glycol

Study type: Interventional

Funder types: Other

Identifiers

NCT03100513

Hanan Soliman

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Lactulose

Active Comparator group

Description:

(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.

Treatment:

Drug: Lactulose

Polyeyhylene Glychol

Active Comparator group

Description:

Polyethylene Glycol 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)

Treatment:

Drug: Polyethylene Glycol