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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

NCT01008293

Chronic Liver Disease Hepatic Encephalopathy

COMPLETED PHASE2/PHASE3

Study of Lactulose in Children With Chronic Liver Disease

NCT00811434

Minimal Hepatic Encephalopathy

TERMINATED PHASE2

S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE

NCT01446523

Hepatic Encephalopathy

COMPLETED NA

Antioxidants and Zinc Improving Minimal Hepatic Encephalopathy In Truck Drivers; a Pilot Study

NCT02520817

Minimal Hepatic Encephalopathy

COMPLETED

Fructans, Lactitol and Lactose in Minimal Hepatic Encephalopathy

NCT02022137

Liver Cirrhosis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Minimal Hepatic Encephalopathy Hepatic Encephalopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactulose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No