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

NCT00375375 | Completed Phase 4

• 1 other identifier: Minimal hepatic encephalopathy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Minimal Hepatic Encephalopathy; Hepatic Encephalopathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improvement in minimal hepatic encephalopathy and health related quality of life

Interventions

Lactulose DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All the patients diagnosed as having cirrhosis of liver

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Uttarakhand, 160012, India

Location

Related Publications (1)

• 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 Mar;45(3):549-59. doi: 10.1002/hep.21533.

  PMID: 17326150 RESULT

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Radha K Dhiman, MD,DM, FACG

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: January 1, 2004
• Study Completion: December 1, 2004
• Last Updated: March 2, 2007

Record last verified: 2007-03

Locations

IN (1)