Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05788627
Other study ID # 700
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT01846806 - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy. N/A
Completed NCT01559519 - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy Phase 4
Recruiting NCT01178372 - Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis Phase 4
Completed NCT00914056 - A Study of Controlled Lactulose Withdrawal N/A
Completed NCT00740142 - Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy Phase 4
Completed NCT00558038 - Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy Phase 2
Completed NCT00986895 - A Study of Glyceryl Tri-(4-phenylbutyrate) Administered Orally as a Single Dose, and Twice Daily for Seven Consecutive Days to Subjects With Hepatic Impairment With Cirrhosis and to a Control Group Phase 1
Completed NCT00287235 - Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS) N/A
Recruiting NCT05539027 - Efficacy of L-Ornithine L-Aspartate (LOLA) as an Adjunct to Branched Chain Amino Acids (BCAA) Enriched Solutions on Clinical Outcomes in ICU Patients With Hepatic Encephalopathy Phase 4
Recruiting NCT04096014 - Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy N/A
Completed NCT05526404 - Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration N/A
Completed NCT04082780 - Rifamycin in Minimal Hepatic Encephalopathy Phase 2
Enrolling by invitation NCT06367127 - Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening
Active, not recruiting NCT05425316 - Speech in Hepatic Encephalopathy (HE)
Recruiting NCT04415294 - Flicker App for Minimal Hepatic Encephalopathy
Not yet recruiting NCT06072521 - Efficacy of Lactoferrin as an Adjunct Therapy in Patients With Hepatic Encephalopathy Phase 2
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A