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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Lactulose

U.S. FDA Resources

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
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:

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]

ClinicalTrials.gov Identifier:	NCT00375375 History of Changes
Other Study ID Numbers:	Minimal hepatic encephalopathy
Study First Received:	September 12, 2006
Last Updated:	March 1, 2007
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

Additional relevant MeSH terms:

Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion

Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012