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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lactulose

Group L receives lactulose Group NL receives placebo

Group Type PLACEBO_COMPARATOR

Lactulose

Intervention Type DRUG

Syrup 30 ml BD for 12 weeks

Placebo

Group NL receives placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Syrup, 30 ml BD for 3 months in Gr. NL

Interventions

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placebo

Syrup, 30 ml BD for 3 months in Gr. NL

Intervention Type DRUG

Lactulose

Syrup 30 ml BD for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Duphalac , Looz

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No