Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

Effectiveness Of Oral Lactulose Versus Lactulose Enema On The Time To Recovery From Overt Hepatic Encephalopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05788627
• Other study ID #: 700
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2023
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Khyber Medical College, Peshawar
• Contact: Aliena Badshah
• Phone: 0092-335-5950615
• Email: aliena.badshah[@]kmc.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hepatic encephalopathy (HE) is defined as neuropsychiatric disorder due to liver failure. It is characterized by mild cognitive impairment, stupor and coma. The most common reasons for pathogenesis include the role of neurotoxins, impaired neurotransmission due to metabolic changes in liver failure, changes in brain energy metabolism, systemic inflammatory response and alterations of the blood brain barrier. Neurotoxin ammonia is related to precipitating HE, for which the gastrointestinal tract is the primary source. Colonic bacteria catabolise the nitrogenous sources into ammonia.

Lactulose is the initial treatment for HE. It produces diarrhea by osmosis and reduces pH of colonic contents, which leads to reduced absorption of ammonia by converting it to ammonium ion (NH4). Understandingly, it does not cure the underlying liver disease however, it does prevent deterioration of the mental status in HE.

Initial oral dose of lactulose is 30 ml once a day or twice daily. For retention enema the dose is 300 ml lactulose plus 700 ml water, administered every 4 hours. It can be increased as tolerated. At least, 2-4 loose stools per day should be passed by the patient.

Lactulose is also effective as primary prophylaxis against the development of HE.

Constipation is one very common precipitating factor for hepatic encephalopathy which is routinely managed with oral lactulose or kleen enema (21.4g (18.1% w/v) Sodium Dihydrogen Phosphate Dihydrate and 9.4g (8.0% w/v) Disodium Phosphate Dodecahydrate). Lactulose enema is also given to patients in hepatic encephalopathy either alone or in combination with oral lactulose. However it is not clear whether there is any difference in the efficacy of oral or enema lactulose in patients with hepatic encephalopathy in terms of improvement of encephalopathy grade and time to improvement. This study aims to determine the efficacy of oral versus enema lactulose in the achievement of these goals.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with dehydration

• Electrolyte abnormalities

• Spontaneous bacterial peritonitis (SBP),

• Fever

• Using sedative / hypnotic medications as predisposing factors for hepatic encephalopathy

Related Conditions & MeSH terms

• Brain Diseases
• Chronic Liver Disease
• Hepatic Encephalopathy
• Liver Diseases

Intervention

Drug:
• Tap water
Oral lactulose in a dose of 30ml BD and tap water enema 1000ml BD
• Lactulose
Oral lactulose in a dose of 30ml BD and lactulose enema (300ml lactulose and 700ml water) in a dose of 1000ml BD.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical College, Peshawar

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relief of constipation	Frequency of 2-3 soft stools per 24 hours	Over 48 hours