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NCT Number: NCT00375375

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

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.

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Key information

Conditions

Minimal Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, 160012, India

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactulose

Drug

Primary outcomes

  1. Improvement in minimal hepatic encephalopathy and health related quality of life

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2004
Study completion
2004
First posted
Sep 13, 2006
Registry last updated
Mar 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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