S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
endtxninHE
Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedApril 10, 2012
April 1, 2012
4 months
September 11, 2011
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement of minimal hepatic encephalopathy
Baseline and at 12 weeks
Secondary Outcomes (1)
correlation between inflammatory mediators and grades of encephalopathy
Baseline and at 12 weeks
Study Arms (2)
Lactulose
PLACEBO COMPARATORGroup L receives lactulose Group NL receives placebo
Placebo
PLACEBO COMPARATORGroup NL receives placebo
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Sharma
New Delhi, National Capital Territory of Delhi, 110060, India
Related Publications (1)
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.
PMID: 23425082DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barjesh c Sharma, DM
GB Pant Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 11, 2011
First Posted
October 5, 2011
Study Start
October 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
April 10, 2012
Record last verified: 2012-04