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

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ClinicalTrials.gov Identifier: NCT00375375
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : March 2, 2007
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Minimal Hepatic Encephalopathy Hepatic Encephalopathy Drug: Lactulose Phase 4

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.)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2004
Estimated Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Improvement in minimal hepatic encephalopathy and health related quality of life

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375375

Postgraduate Institute of Medical Education and Research
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Principal Investigator: Radha K Dhiman, MD,DM, FACG Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
More Information

ClinicalTrials.gov Identifier: NCT00375375     History of Changes
Other Study ID Numbers: Minimal hepatic encephalopathy
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: March 2, 2007
Last Verified: March 2007

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 Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Gastrointestinal Agents