NASH Related Decompensated CirrhosisNCT02868164
Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
A study testing Fecal Microbiota Transplantation, Standard Treatment and Weight Reduction in people with NASH Related Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study will be conducted in the Department of Hepatology, Institute of Liver \& Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NASH Related Decompensated Cirrhosis
- What is being tested?
- Fecal Microbiota Transplantation, Standard Treatment and Weight Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2018to Feb 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years.
- All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
- No history of recent spontaneous bacterial peritonitis.(1 month)
- Child Pugh Score of 6 - 10
Who cannot join
- Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
- Ongoing bacterial infection requiring antibiotic treatment.
- Current or history of significant alcohol consumption for a period of more than 3
- consecutive months within 1 year prior to screening
- Treatment with antibiotics or probiotics in the preceding 3 months.
- Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
- Pregnant patients
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
The study will be conducted in the Department of Hepatology, Institute of Liver \& Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.
- Conditions
- NASH Related Decompensated Cirrhosis
- Being tested
- Fecal Microbiota Transplantation, Standard Treatment, Weight Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationDrug
The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
Standard Treatment
Weight ReductionOther
routine exercise for weight reduction
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | Not described Receives: Drug: Fecal Microbiota Transplantation |
| Weight Reduction | Active comparator | Not described Receives: Drug: Standard Treatment; Other: Weight Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
Measured: 1 year
Secondary outcomes (7)
Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month
Measured: 1 year
Improvement in liver function test as compared to baseline in both groups.
Measured: 1 year
Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.
Measured: 1 year
Improvement duodenal biopsy as compared to baseline in both groups.
Improvement is defined as improvement in microbiome pre and post treatment.
Measured: 1 year
Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.
Measured: 1 year
Improvement in insulin resistance in both groups.
Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR
Measured: 1 year
Reduction in hepatic and systemic inflammatory markers in both groups
Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startFeb 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Why it stopped: lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH Related Decompensated 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
- Investigators
- Dr Kapil Dev Jamwal, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868164
- Sponsor's protocol ID
- ILBS-Cirrhosis-05
- Status last verified
- Feb 2018
- First submitted
- 4 Aug 2016
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02868164
- Acronym / sponsor ID
- ILBS-Cirrhosis-05
- Conditions
- NASH Related Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 16 Aug 2016 (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 study will be conducted in the Department of Hepatology, Institute of Liver \& Biliary Sciences, New Delhi. As a part of this study history will be taken and clinical examination will be done. Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis. If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines. The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose. This administration of sample, 50 ml daily will occur once a month every month for 6 months. The liver function parameters will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | Drug: Fecal Microbiota Transplantation |
| Weight Reduction | Active comparator | Drug: Standard Treatment, Other: Weight Reduction |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age more than 18 years.
- All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
- No history of recent spontaneous bacterial peritonitis.(1 month)
- Child Pugh Score of 6 - 10
Key exclusion criteria (7 listed)
- Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
- Ongoing bacterial infection requiring antibiotic treatment.
- Current or history of significant alcohol consumption for a period of more than 3
- consecutive months within 1 year prior to screening
- Treatment with antibiotics or probiotics in the preceding 3 months.
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 |
|---|---|---|
| Fecal Microbiota TransplantationThe recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month. | Drug | Fecal Microbiota Transplantation (FMT) |
| Standard TreatmentStandard Treatment | Drug | Weight Reduction |
| Weight Reductionroutine exercise for weight reduction | Other | Weight Reduction |
Primary outcome
Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
Time frame: 1 year
Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
7 secondary outcomes
Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month
Time frame: 1 year
Improvement in liver function test as compared to baseline in both groups.
Time frame: 1 year
Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.
Time frame: 1 year
Improvement duodenal biopsy as compared to baseline in both groups.
Time frame: 1 year
Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.
Time frame: 1 year
Improvement in insulin resistance in both groups.
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers in both groups
Time frame: 1 year
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 1 Nov 2019.
- Individual participant dataSharing planned: Undecided
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.
Dr Kapil Dev Jamwal, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation, Standard Treatment and Weight Reduction in people with NASH Related Decompensated 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 5 inclusion and 7 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 1 Nov 2019. 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 adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups (time frame: 1 year). 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 1 Nov 2019.