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

NCT03100513 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-27

No results posted yet for this study

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.

Conditions

  • Hepatic Encephalopathy

Interventions

DRUG

Lactulose

(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

DRUG

Polyethylene 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).

Sponsors & Collaborators

  • Sherief Abd-Elsalam

    lead OTHER

Principal Investigators

  • Hanan Soliman, MD · Tanta University Faculty of Medicine

  • Amany Abd El-Rahim Abdin, MD · Tanta university Faculty of Pharmacy

  • Samah Mosaad Soliman, MD · Tanta University Faculty of Medicine

  • Hala Hany Shehata, Msc · Tanta University Faculty of Medicine

  • Sherief Abd-Elsalam, MD · Tanta University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-11
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100513 on ClinicalTrials.gov