Liver CirrhosisNCT03161106
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
A study testing Nutrition, Lactulose and Diet in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi . Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Nutrition, Lactulose and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2017to 1 Oct 2018
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Liver cirrhosis (Child B or Child C class)
- Age between 18-60 years
- History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Who cannot join
- Evidence of overt hepatic encephalopathy at the time of enrollment
- History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
- Alcohol intake during past 6 weeks
- Receiving secondary prophylaxis for spontaneous bacterial peritonitis
- Previous transjugular intrahepatic portosystemic shunts or shunt surgery
- Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies
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- Receiving psychoactive drugs, promotility and hypomotility drugs
- Hepatocellular carcinoma
- Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
- Intercurrent infection such as spontaneous bacterial peritonitis
- Patients of acute on chronic liver failure (ACLF).
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial
The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .
Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.
- Conditions
- Liver Cirrhosis
- Being tested
- Nutrition, Lactulose, Diet
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutritionDietary supplement
Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
LactuloseDrug
Lactulose plus diet consumed by patient
DietDietary supplement
Protein Powder 15 to 20 gm/meal/day
| Study group | Role | What they receive |
|---|---|---|
| Nutrional Therapy Group | Experimental | Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months Receives: Dietary Supplement: Nutrition |
| Lactulose Group | Active comparator | Lactulose - 20 mL thrice daily (maximum) for 6 months Receives: Drug: Lactulose; Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients develop hepatic encephalopathy in both groups
Measured: 6 Months
Secondary outcomes (7)
Improvement in health related quality of life over 6 months
Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).
Measured: 6 Months
Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months
Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip
Measured: 6 Months
Time taken for first breakthrough episode of overt hepatic encephalopathy
Measured: 6 Months
Time to first overt hepatic encephalopathy-related hospital admission
Measured: 6 Months
Mortality over 6 months
Measured: 6 Months
Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)
Measured: 6 Months
Changes in Stool microbiota for 20 patients
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start15 May 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Why it stopped: due lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161106
- Sponsor's protocol ID
- ILBS-Cirrhosis-12
- Status last verified
- Jun 2018
- First submitted
- 8 May 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03161106
- Acronym / sponsor ID
- ILBS-Cirrhosis-12
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 19 May 2017 (actual)
- 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 study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .
Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrional Therapy Group | Experimental | Dietary Supplement: NutritionNutritional group- Protein of 1.5 gm/kg thrice daily for 6 months |
| Lactulose Group | Active comparator | Drug: Lactulose, Dietary Supplement: DietLactulose - 20 mL thrice daily (maximum) for 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Liver cirrhosis (Child B or Child C class)
- Age between 18-60 years
- History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
Key exclusion criteria (11 listed)
- Evidence of overt hepatic encephalopathy at the time of enrollment
- History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days
- Alcohol intake during past 6 weeks
- Receiving secondary prophylaxis for spontaneous bacterial peritonitis
- Previous transjugular intrahepatic portosystemic shunts or shunt surgery
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 |
|---|---|---|
| NutritionNutrional group-30 kcal/kg with 1.5 grm protein with protein supplements | Dietary supplement | Nutrional Therapy Group |
| LactuloseLactulose plus diet consumed by patient | Drug | Lactulose Group |
| DietProtein Powder 15 to 20 gm/meal/day | Dietary supplement | Lactulose Group |
Primary outcome
Number of patients develop hepatic encephalopathy in both groups
Time frame: 6 Months
7 secondary outcomes
Improvement in health related quality of life over 6 months
Time frame: 6 Months
Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months
Time frame: 6 Months
Time taken for first breakthrough episode of overt hepatic encephalopathy
Time frame: 6 Months
Time to first overt hepatic encephalopathy-related hospital admission
Time frame: 6 Months
Mortality over 6 months
Time frame: 6 Months
Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)
Time frame: 6 Months
Changes in Stool microbiota for 20 patients
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition, Lactulose and Diet in people with Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India 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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 11 Dec 2018. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients develop hepatic encephalopathy in both groups (time frame: 6 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 11 Dec 2018.