Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life - Full Text View

Sponsored by:	Postgraduate Institute of Medical Education and Research
Information provided by:	Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:	NCT00375375

Purpose

Minimal hepatic encephalopathy (MHE) has a negative effect on patients’ daily functioning. No study has so far investigated the effect of treatment related improvement in cognitive functions on health related quality-of-life (HRQOL). This study was carried out to determine the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.

The mean number of abnormal NP tests decreased significantly in patients in treated group compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total SIP score improved among patients in the treated group after 3 months compared with patients in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose improves both cognitive functions and HRQOL in cirrhotic patients with MHE.

Condition	Intervention	Phase
Minimal Hepatic Encephalopathy Hepatic Encephalopathy	Drug: Lactulose	Phase IV

Drug Information available for: Lactulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:

Improvement in minimal hepatic encephalopathy and health related quality of life

Estimated Enrollment:	80
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2004

Detailed Description:

The study has been published in March 2007 in Hepatology

Lactulose Improves Cognitive Functions and Health-Related Quality of Life in Patients with Cirrhosis WhoHave Minimal Hepatic Encephalopathy.Srinivasa Prasad, Radha K. Dhiman, Ajay Duseja, Yogesh K. Chawla, Arpita Sharma, and Ritesh Agarwal. (HEPATOLOGY 2007;45:549-559.)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All the patients diagnosed as having cirrhosis of liver

Exclusion Criteria:

Overt HE or a history of overt HE;
History of recent (< 6 weeks) alcohol intake;
Infection, recent (< 6 weeks) antibiotic use or gastrointestinal bleeding;
History of recent (< 6 weeks) use of drugs affecting psychometric
Performances like benzodiazepens, antiepileptics, psychotropic drugs;
History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension;
Electrolyte imbalance;
Renal impairment;
Presence of hepatocellular carcinoma;
Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement;
Inability to perform NP tests and to complete the SIP questionnaire due to bad vision.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375375

Locations

India, UT
Postgraduate Institute of Medical Education and Research
Chandigarh, UT, India, 160012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

Principal Investigator:

Radha K Dhiman, MD,DM, FACG

Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India

More Information

Publications of Results:

Prasad S, Dhiman RK, Duseja A, Chawla YK, Sharma A, Agarwal R. Lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis who have minimal hepatic encephalopathy. Hepatology. 2007 Feb 26;45(3):549-559 [Epub ahead of print]

Study ID Numbers:	Minimal hepatic encephalopathy
Study First Received:	September 12, 2006
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00375375
Health Authority:	India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:

Minimal hepatic encephalopathy
Hepatic encephalopathy
Subclinical hepatic encephalopathy
Health related quality of life

Study placed in the following topic categories:

Liver Diseases
Neurotoxicity Syndromes
Brain Damage, Chronic
Quality of Life
Disorders of Environmental Origin
Brain Diseases
Signs and Symptoms
Mental Disorders
Brain Injuries
Dementia
Neurobehavioral Manifestations
Lactulose
Hepatic Insufficiency
Delirium
Liver Failure

Metabolic Diseases
Neurotoxicity syndromes
Poisoning
Central Nervous System Diseases
Confusion
Encephalitis
Cognition Disorders
Virus Diseases
Hepatic Encephalopathy
Digestive System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Central Nervous System Infections
Neurologic Manifestations
Metabolic disorder
Brain Diseases, Metabolic

Additional relevant MeSH terms:

Therapeutic Uses
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Viral Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009