Chronic Liver DiseasePhase 2/3MHENCT01008293
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
A Phase 2/3 study testing VSL#3 and Lactulose in people with Chronic Liver Disease and Hepatic Encephalopathy, run by CD Pharma India Pvt. Ltd. at 1 site in India.
Trial summary
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: To study the health related quality of life (HRQOL) in patients with chronic liver disease. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Chronic Liver Disease, Hepatic Encephalopathy
- What is being tested?
- VSL#3 and Lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Oct 2012
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.
Who cannot join
- Patients with overt hepatic encephalopathy
- Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
- Malignancy
- History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
- Presence of other neurological or psychiatric disorder
- Patients who underwent shunt surgery for portal hypertension
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- History of taking medicines likely to interfere with psychometric performance
- History of GI hemorrhage or spontaneous bacterial peritonitis during the past 6 weeks
- Presence of mature cataracts and diabetic retinopathy
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Dept. of Gastroenterology and H.N.U., All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Health Related Quality of Life in Patient With Chronic Liver Disease and Effect of Probiotics in the Treatment of MHE and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below:
- To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE.
- To compare the effect of probiotics and lactulose in the treatment of MHE
- To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
Read the detailed description
The study design would comprise of two parts
- Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
- All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
- Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
- The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
- The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
- Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared.
- All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
- All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
- The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.
- Conditions
- Chronic Liver Disease, Hepatic Encephalopathy
- Being tested
- VSL#3, Lactulose
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Drug
VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus)
LactuloseDrug
Also called Duphalac
30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools.
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 | Experimental | Not described Receives: Drug: VSL#3 |
| Lactulose | Active comparator | 30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- CD Pharma India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research, All India Institute of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Y K Joshi, Prof., Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008293
- Sponsor's protocol ID
- MHE-VSL3-YKJ_AIIMS_ver1
- Acronym
- MHE
- Status last verified
- Jun 2013
- First submitted
- 4 Nov 2009
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life in Patient With Chronic Liver Disease and Effect of Probiotics in the Treatment of MHE and Health Related Quality of Life
- ClinicalTrials.gov ID
- NCT01008293
- Acronym / sponsor ID
- MHE / MHE-VSL3-YKJ_AIIMS_ver1
- Conditions
- Chronic Liver Disease, Hepatic Encephalopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- CD Pharma India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Indian Council of Medical Research, All India Institute of Medical Sciences
- Study start
- Oct 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Nov 2009 (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.
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below:
- To study the health related quality of life (HRQOL) in patients with chronic liver disease.
- To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE.
- To compare the effect of probiotics and lactulose in the treatment of MHE
- To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
Detailed description
The study design would comprise of two parts
- Part I: Cross sectional study: This part would comprise of the assessment of HRQOL in patients with CLD
- All the consecutive patients diagnosed as CLD would be enrolled in the study. All these patients would be enrolled from the liver clinics of the department of gastroenterology and those admitted in the gastroenterology ward at AIIMS.
- Alcohol would be considered to be the cause of CLD, if the patient regularly consumed ≥80g/d of alcohol for five years
- The staging of cirrhosis would be done according to the Child Pugh classification: A, B and C
- The causes of CLD would be divided into:- viral hepatitis, alcohol, viral hepatitis combining with alcohol and miscellaneous causes
- Part II: Prospective randomized controlled trial: In this part the outcome of lactulose and probiotic therapy in the treatment of MHE and its effect on the HRQOL will be compared.
- All the consecutive patients with CLD without overt encephalopathy would be screened for MHE.
- All these patients would be enrolled from the liver clinics and the gastroenterology ward, AIIMS.
- The diagnosis of MHE would be based on abnormal psychometric tests (NCT-A and NCT-B or FCT-A and FCT-B) and /or abnormal P300 auditory event related potentials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSL#3 | Experimental | Drug: VSL#3 |
| Lactulose | Active comparator | Drug: Lactulose30-60 ml of lactulose per day (2 months) to ensure 2-3 soft stools |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients with Chronic Liver Disease or Minimal Hepatic Encephalopathy (without overt hepatic encephalopathy) aged between 15 to 80 years of both the genders would be enrolled consecutively.
Key exclusion criteria (10 listed)
- Patients with overt hepatic encephalopathy
- Active medical co-morbidities like CHD, chronic respiratory disease, chronic renal disease, malignancies, diabetes etc
- Malignancy
- History of taking lactulose or probiotics or antibiotics, in the past 6 weeks
- Presence of other neurological or psychiatric disorder
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 |
|---|---|---|
| VSL#3VSL#3 (2 capsules bid.for 2 months, Each containing 112.5 billion viable lyophilized bacteria). Each capsule contains 4 strains of Lactobacillus (L. casei, L. plantarum, L. acidophilus, and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, L. breve, and B. infantis), and 1 strain of Streptococcus salivarius subsp. thermophilus (designated hereafter as S. thermophilus) | Drug | VSL#3 |
| LactuloseAlso: Duphalac30-60 ml of lactulose per day for 2 months to ensure 2-3 soft stools. | Drug | Lactulose |
Primary outcome
To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL
Time frame: 2 months
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 4 Jun 2013.
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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.
Y K Joshi, Prof. principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VSL#3 and Lactulose in people with Chronic Liver Disease and Hepatic Encephalopathy, run by CD Pharma India Pvt. Ltd. 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 4 Jun 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2013.