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

Hepatic Encephalopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375375
• Other study ID #: Minimal hepatic encephalopathy
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2006
• Last updated: March 1, 2007
• Start date: January 2004
• Est. completion date: December 2004

Study information

• Verified date: March 2007
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy
• Minimal Hepatic Encephalopathy

Intervention

Drug:
• Lactulose

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh	UT

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in minimal hepatic encephalopathy and health related quality of life