Clinical Trials Logo
  1. Home
  2. Hepatic Encephalopathy
  3. NCT01178372

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis — HE  

Hepatic Encephalopathy Clinical Trial

Official title:
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy

Clinical Trial Summary

Hepatic encephalopathy (HE), a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis. The treatment of choice is non-absorbable disaccharides, such as lactulose and lactitol.Probiotics are effective in the treatment of minimal hepatic encephalopathy which precipitates hepatic encephalopathy. The investigators will assess the effects of lactulose and probiotics for the prevention of recurrence of HE (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy.

Clinical Trial Description

Hepatic encephalopathy, a challenging complication of advanced liver disease, occurs in approximately 30-45% of patients with cirrhosis and 10-50% of patients with transjugular intrahepatic portosystemic shunt.Although the occurrence of episodes of hepatic encephalopathy appears to be unrelated to the cause of cirrhosis,increases in the frequency and severity of such episodes predict an increased risk of death.A small metaanalysis determined that lactulose and lactitol were equally effective in the treatment of HE.Probiotics alter the gut flora resulting in decreased ammonia production and absorption due to decreased intraluminal pH. Also shown to alter the short chain fatty acid production, & decrease intestinal permeability.Various studies have shown some improvement in either the prevalence of minimal hepatic encephalopathy or results in neuropsychological tests with the use of probiotics.Lactulose and probiotics improves minimal hepatic encephalopathy in cirrhotic patients and it has also been shown that minimal hepatic encephalopathy predisposes the cirrhotic patient to HE.We will assess the effects of lactulose and probiotics for the prevention of recurrence of hepatic encephalopathy (secondary prophylaxis) in patients after the recovery of an episode of overt hepatic encephalopathy. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01178372
Study type Interventional
Source Govind Ballabh Pant Hospital
Contact
Status Recruiting
Phase Phase 4
Start date September 2008
Completion date September 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT01559519 - Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic Encephalopathy Phase 4
Terminated NCT01846806 - The Role of Bacterial Overgrowth and Delayed Intestinal Transit in Hepatic Encephalopathy. N/A
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
Completed NCT02636647 - Fecal Transplant in Recurrent Hepatic Encephalopathy Phase 1
Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
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
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3