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

Govind Ballabh Pant Hospital

Status

Completed

Conditions

Hepatic Encephalopathy

Treatments

Drug: Lactulose

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01446523

endotoxins in MHE

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

15 to 70 years old

Volunteers

No 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