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

Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01446523

Acronym

endtxninHE

Enrollment

Registered

2011-10-05

Start date

2011-10-31

Completion date

2012-02-29

Last updated

2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

endotoxins HE

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.

Interventions

DRUGplacebo

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

DRUGLactulose

Syrup 30 ml BD for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement of minimal hepatic encephalopathy	Baseline and at 12 weeks

Secondary

Measure	Time frame	Description
correlation between inflammatory mediators and grades of encephalopathy	Baseline and at 12 weeks	To measure values of inflammatory mediators in different grades of encephalopathy

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026