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

This study has been completed.
Information provided by (Responsible Party):
Barjesh Chander Sharma, Govind Ballabh Pant Hospital Identifier:
First received: September 11, 2011
Last updated: April 9, 2012
Last verified: April 2012
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.

Condition Intervention
Hepatic Encephalopathy Drug: placebo Drug: Lactulose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy

Resource links provided by NLM:

Further study details as provided by Barjesh Chander Sharma, Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Improvement of minimal hepatic encephalopathy [ Time Frame: Baseline and at 12 weeks ]

Secondary Outcome Measures:
  • correlation between inflammatory mediators and grades of encephalopathy [ Time Frame: Baseline and at 12 weeks ]
    To measure values of inflammatory mediators in different grades of encephalopathy

Enrollment: 60
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactulose
Group L receives lactulose Group NL receives placebo
Drug: Lactulose
Syrup 30 ml BD for 12 weeks
Other Name: Duphalac , Looz
Placebo Comparator: Placebo
Group NL receives placebo
Drug: placebo
Syrup, 30 ml BD for 3 months in Gr. NL

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.


Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01446523

BC Sharma
New Delhi, Delhi, India, 110060
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Principal Investigator: Barjesh c Sharma, DM GB Pant Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Barjesh Chander Sharma, Professor, Govind Ballabh Pant Hospital Identifier: NCT01446523     History of Changes
Other Study ID Numbers: endotoxins in MHE
Study First Received: September 11, 2011
Last Updated: April 9, 2012

Keywords provided by Barjesh Chander Sharma, Govind Ballabh Pant Hospital:
endotoxins HE

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Gastrointestinal Agents processed this record on August 18, 2017