NCT03100513

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

March 24, 2017

Last Update Submit

April 25, 2017

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

  • 1 or more in HE grade improvement at 24 hours

    HE grade improvement at 24 hours

    24 hours

Secondary Outcomes (2)

  • Time to HE resolution

    2 weeks

  • Overall length of stay

    2 weeks

Study Arms (2)

Lactulose

ACTIVE COMPARATOR

(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: Lactulose

Polyeyhylene Glychol

ACTIVE COMPARATOR

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)

Drug: Polyethylene Glycol

Interventions

LactuloseDRUG

(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

Also known as: Duphlac, lactulose
Lactulose
Polyethylene GlycolDRUG

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).

Polyeyhylene Glychol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patients with Overt Hepatic Encephalopathy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical medicine dept.-Tanta university hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

LactulosePolyethylene Glycols

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Hanan Soliman, MD

    Tanta University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Amany Abd El-Rahim Abdin, MD

    Tanta university Faculty of Pharmacy

    STUDY DIRECTOR

  • Samah Mosaad Soliman, MD

    Tanta University Faculty of Medicine

    STUDY DIRECTOR

  • Hala Hany Shehata, Msc

    Tanta University Faculty of Medicine

    STUDY CHAIR

  • Sherief Abd-Elsalam, MD

    Tanta University Faculty of Medicine

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201095159522Sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Ass Prof. Hepatology and Gastroenterology

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 4, 2017

Study Start

March 11, 2017

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

EG(1)