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

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
placebo
Lactulose
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring endotoxins HE

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • BC Sharma

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

Lactulose

Placebo

Arm Description

Group L receives lactulose Group NL receives placebo

Group NL receives placebo

Outcomes

Primary Outcome Measures

Improvement of minimal hepatic encephalopathy

Secondary Outcome Measures

correlation between inflammatory mediators and grades of encephalopathy
To measure values of inflammatory mediators in different grades of encephalopathy

Full Information

First Posted
September 11, 2011
Last Updated
April 9, 2012
Sponsor
Govind Ballabh Pant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01446523
Brief Title
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
Acronym
endtxninHE
Official Title
Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
endotoxins HE

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactulose
Arm Type
Placebo Comparator
Arm Description
Group L receives lactulose Group NL receives placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group NL receives placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Syrup, 30 ml BD for 3 months in Gr. NL
Intervention Type
Drug
Intervention Name(s)
Lactulose
Other Intervention Name(s)
Duphalac , Looz
Intervention Description
Syrup 30 ml BD for 12 weeks
Primary Outcome Measure Information:
Title
Improvement of minimal hepatic encephalopathy
Time Frame
Baseline and at 12 weeks
Secondary Outcome Measure Information:
Title
correlation between inflammatory mediators and grades of encephalopathy
Description
To measure values of inflammatory mediators in different grades of encephalopathy
Time Frame
Baseline and at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barjesh c Sharma, DM
Organizational Affiliation
GB Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Sharma
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
23425082
Citation
Jain L, Sharma BC, Srivastava S, Puri SK, Sharma P, Sarin S. Serum endotoxin, inflammatory mediators, and magnetic resonance spectroscopy before and after treatment in patients with minimal hepatic encephalopathy. J Gastroenterol Hepatol. 2013 Jul;28(7):1187-93. doi: 10.1111/jgh.12160.
Results Reference
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S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE

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