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Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05788627
Enrollment
100
Registered
2023-03-29
Start date
2023-04-30
Completion date
2023-11-30
Last updated
2023-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy, Chronic Liver Disease

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.

Detailed 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.

Interventions

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

DRUGLactulose

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

Sponsors

Khyber Medical College, Peshawar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in grade of hepatic encephalopathyOver 48 hoursChange in HE grade from grade 4 to grade 3 or grade 3 to grade 2

Secondary

MeasureTime frameDescription
Relief of constipationOver 48 hoursFrequency of 2-3 soft stools per 24 hours

Contacts

Primary ContactAliena Badshah
aliena.badshah@kmc.edu.pk0092-335-5950615

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026