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

Not Applicable

Completed

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Lactulose; Drug: placebo

• Registration Number: NCT01446523
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.

Detailed Description

60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion \& exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group).

Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.

Study Timeline

• Study First Submitted: 2011-09-11
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-02
• Study First Posted: 2011-10-05
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-09
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )

Exclusion Criteria

• Recent history of gastrointestinal bleed in last 6 weeks
• Active ongoing infection
• Creatinine >1.5mg%
• Electrolyte impairment. (S. Sodium < 130 meq/L, S. Potassium 3.5 meq/L or >5.0meq/L)
• H/O use of psychotropic drugs in last 6 weeks
• Recent alcohol use (< 6 week )
• H/O TIPS or shunt surgery.
• Hepatocellular Carcinoma
• Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life
• Poor vision precluding neuropsychological assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose	Lactulose	Group L receives lactulose Group NL receives placebo
Placebo	placebo	Group NL receives placebo

Primary Outcome Measures

Name	Time	Method
Improvement of minimal hepatic encephalopathy	Baseline and at 12 weeks

Secondary Outcome Measures

Name	Time	Method
correlation between inflammatory mediators and grades of encephalopathy	Baseline and at 12 weeks	To measure values of inflammatory mediators in different grades of encephalopathy

Trial Locations

Locations (1)

BC Sharma; 🇮🇳 New Delhi, Delhi, India