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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01446523
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : April 10, 2012
Information provided by (Responsible Party):
Barjesh Chander Sharma, 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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: placebo Drug: Lactulose Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose
U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01446523

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

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
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 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