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

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ClinicalTrials.gov Identifier: NCT03100513
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Lactulose Drug: Polyethylene Glycol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing The Efficacy of PEG (Polyethylene Glycol) Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
Actual Study Start Date : March 11, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Active Comparator: 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: 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
Other Name: Duphlac, lactulose

Active Comparator: Polyeyhylene Glychol
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
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).




Primary Outcome Measures :
  1. 1 or more in HE grade improvement at 24 hours [ Time Frame: 24 hours ]
    HE grade improvement at 24 hours


Secondary Outcome Measures :
  1. Time to HE resolution [ Time Frame: 2 weeks ]
    Time to Hepatic encephalopathy resolution

  2. Overall length of stay [ Time Frame: 2 weeks ]
    Overall length of stay



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100513


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201095159522 Sheriefabdelsalam@yahoo.com

Locations
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Egypt
Tropical medicine dept.-Tanta university hospital Recruiting
Cairo, Egypt
Contact: Sherief Abd-Elsalam       Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Hanan Soliman, MD Tanta University Faculty of Medicine
Study Director: Amany Abd El-Rahim Abdin, MD Tanta university Faculty of Pharmacy
Study Director: Samah Mosaad Soliman, MD Tanta University Faculty of Medicine
Study Chair: Hala Hany Shehata, Msc Tanta University Faculty of Medicine
Study Chair: Sherief Abd-Elsalam, MD Tanta University Faculty of Medicine

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Responsible Party: Sherief Abd-Elsalam, Clinical Ass Prof. Hepatology and Gastroenterology, Tanta University
ClinicalTrials.gov Identifier: NCT03100513     History of Changes
Other Study ID Numbers: Hanan Soliman
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents