Encephalopathy, Hepatic Clinical Trial
Official title:
A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy
Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic
and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying
severity.
Treatment options include lactulose administered orally or by nasogastric tube or enema,
non-absorbable antibiotics, and protein-restricted diets.
Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by
Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective
study at the 2008 American Association for the Study of Liver Diseases meeting showing
clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.
Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic
and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying
severity.
Hepatic encephalopathy is caused by accumulation of nitrogenous substances, primarily
ammonia, in the blood. In advanced stages it is referred to as hepatic coma which may be
preceded by seizures. The treatment goal is to reduce nitrogen load from the GI tract and to
improve central nervous system (CNS) status.
Treatment options include lactulose administered orally or by nasogastric tube or enema,
non-absorbable antibiotics, and protein-restricted diets.
Lactulose is nonabsorbable disaccharides that are currently used as first line agents for the
treatment of HE. Its action is thought to beconversion to lactic acid and acetic acid
resulting in acidification of the gut lumen. This favors conversion of ammonia (NH3) to
ammonium (NH4+), which is relatively membrane impermeable, and inhibits ammoniagenic coliform
bacteria.
Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by
Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented a pilot prospective
study at the 2008 American Association for the Study of Liver Diseases meeting showing
clinical improvement in HE among cirrhotic patients who received nitazoxanide and lactulose.
Mantry and colleagues showed that the number of hospitalizations and the duration of hospital
stays were shortened for patients receiving combination therapy compared with those receiving
lactulose monotherapy.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00553423 -
Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
|
Phase 3 | |
| Recruiting |
NCT01597102 -
Cerebrovascular Autoregulation During and After Liver Transplantation
|