Hepatic EncephalopathyendtxninHENCT01446523
S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE
A study testing Lactulose in people with Hepatic Encephalopathy, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )
Who cannot join
- 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 )
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
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.
Read the 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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- placebo, Lactulose
- Keywords
- endotoxins HE
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Syrup, 30 ml BD for 3 months in Gr. NL
LactuloseDrug
Also called Duphalac , Looz
Syrup 30 ml BD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lactulose | Placebo comparator | Group L receives lactulose Group NL receives placebo Receives: Drug: Lactulose |
| Placebo | Placebo comparator | Group NL receives placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of minimal hepatic encephalopathy
Measured: Baseline and at 12 weeks
Secondary outcomes (1)
correlation between inflammatory mediators and grades of encephalopathy
To measure values of inflammatory mediators in different grades of encephalopathy
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barjesh Chander Sharma, Govind Ballabh Pant Hospital
- Investigators
- Barjesh c Sharma, DM, Principal investigator, GB Pant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446523
- Sponsor's protocol ID
- endotoxins in MHE
- Acronym
- endtxninHE
- Status last verified
- Apr 2012
- First submitted
- 11 Sep 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23425082
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT01446523
- Acronym / sponsor ID
- endtxninHE / endotoxins in MHE
- Conditions
- Hepatic Encephalopathy
- Keywords
- endotoxins HE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose | Placebo comparator | Drug: LactuloseGroup L receives lactulose Group NL receives placebo |
| Placebo | Placebo comparator | Drug: placeboGroup NL receives placebo |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboSyrup, 30 ml BD for 3 months in Gr. NL | Drug | Placebo |
| LactuloseAlso: Duphalac , LoozSyrup 30 ml BD for 12 weeks | Drug | Lactulose |
Primary outcome
Improvement of minimal hepatic encephalopathy
Time frame: Baseline and at 12 weeks
1 secondary outcome
correlation between inflammatory mediators and grades of encephalopathy
Time frame: Baseline and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
- Derived from this study: PubMed 23425082Jain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barjesh c Sharma, DM principal investigator
GB Pant Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose in people with Hepatic Encephalopathy, run by Govind Ballabh Pant Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of minimal hepatic encephalopathy (time frame: Baseline and at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2012.