Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

NCT05788627 | Unknown Phase 4

• 1 other identifier: 700
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with chronic liver disease due to hepatitis B or C viruses, Non-alcoholic fatty liver disease, autoimmune hepatitis, wilson disease, cryptogenic hepatitis etc are prone to develop complications. Hepatic encephalopathy is one of such complications. It is graded into four types depending on severity of clinical features, which range through altered sleep pattern to coma. The current study aims to compare the effectiveness of lactulose enema with oral lactulose in time to recovery from higher grade of encephalopathy to lower grade of encephalopathy.

Conditions

Hepatic Encephalopathy; Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• Change in grade of hepatic encephalopathy

  Change in HE grade from grade 4 to grade 3 or grade 3 to grade 2

  Over 48 hours

Secondary Outcomes (1)

• Relief of constipation

  Over 48 hours

Study Arms (2)

Placebo arm / tap water enema arm

PLACEBO COMPARATOR

This arm will receive oral lactulose as per treatment protocol for hepatic encephalopathy i.e. 30ml twice daily. And will receive tap water enema as placebo i.e. 1000ml tap water enema twice daily.

Drug: Tap water

Lactulose enema arm

EXPERIMENTAL

This arm will receive oral lactulose in a dose of 30ml twice daily alongwith lactulose enema (300ml lactulose plus 700ml water) twice daily.

Drug: Lactulose

Interventions

Tap water DRUG

Oral lactulose in a dose of 30ml BD and tap water enema 1000ml BD

Also known as: tap water enema

Placebo arm / tap water enema arm

Lactulose DRUG

Oral lactulose in a dose of 30ml BD and lactulose enema (300ml lactulose and 700ml water) in a dose of 1000ml BD.

Also known as: Lactulose enema

Lactulose enema arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female cirrhotic patients in grades 3 or 4 of hepatic encephalopathy
• Patient with constipation as the precipitating factor will be included in the study

You may not qualify if:

• Patients with dehydration
• Electrolyte abnormalities
• Spontaneous bacterial peritonitis (SBP),
• Fever
• Using sedative / hypnotic medications as predisposing factors for hepatic encephalopathy

Sponsors & Collaborators

• Khyber Medical College, Peshawar: lead

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Aliena Badshah

  Khyber Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliena Badshah

CONTACT

0092-335-5950615; aliena.badshah@kmc.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 29, 2023
• Study Start: April 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available once patients are recruited into the study
• Access Criteria: not specified yet