Non Alcoholic SteatohepatitisNCT02721264
Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.
A study testing Fecal Microbiota Transplant and Standard Medical Treatment in people with Non Alcoholic Steatohepatitis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- Fecal Microbiota Transplant and Standard Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2016to 30 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more then 18 years.
- All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- Histologic evidence of definite or probable NASH based upon a liver biopsy prior to enrollment and a NAFLD 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 past history of upper GI bleeding, ascites, hepatic encephalopathy
Who cannot join
- Diagnosis of liver disease other than NASH cirrhosis
- History of gastrointestinal bleeding, ascites, hepatic encephalopathy
- 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 or perform an upper GI endoscopy
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- Psychiatric disorder
- HIV
- Pregnant women
- Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial
Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- Fecal Microbiota Transplant, Standard Medical Treatment
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantBiological
Standard Medical TreatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month. Receives: Biological: Fecal Microbiota Transplant |
| Standard Treatment Care | Active comparator | Not described Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
Measured: 1 year
Secondary outcomes (11)
Improvement in liver function test as compared to baseline.
Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits
Measured: 1 year
Improvement in Liver Stiffness Measurement as compared to baseline.
LSM < 10 Kpa
Measured: 1 year
Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)
HOMA IR <2.5
Measured: 1 year
Incidence of new onset upper gastrointestinal bleed in both groups
Measured: 1 year
development of new onset of ascites in both groups.
Measured: 1 year
Number of Spontaneous Bacterial peritonitis cases in both groups.
Measured: 1 year
ACLF (Acute on Chronic Liver failure) cases in both groups.
Measured: 1 year
Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups
Measured: 1 year
Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups
Measured: 1 year
Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.
Measured: 1 year
Histological and permeability changes in the duodenal biopsy in both groups.
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 posted29 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
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 Non Alcoholic SteatohepatitisStudies 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Abhinav Verma, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721264
- Sponsor's protocol ID
- ILBS-NASH-03
- Status last verified
- Feb 2018
- First submitted
- 1 Mar 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025.
PubMed 40568349
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02721264
- Acronym / sponsor ID
- ILBS-NASH-03
- Conditions
- Non Alcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 29 Mar 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.
Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.
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 | Biological: Fecal Microbiota TransplantThe recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month. |
| Standard Treatment Care | Active comparator | Other: Standard Medical Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age more then 18 years.
- All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- Histologic evidence of definite or probable NASH based upon a liver biopsy prior to enrollment and a NAFLD 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 past history of upper GI bleeding, ascites, hepatic encephalopathy
Key exclusion criteria (10 listed)
- Diagnosis of liver disease other than NASH cirrhosis
- History of gastrointestinal bleeding, ascites, hepatic encephalopathy
- 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 Transplant | Biological | Fecal Microbiota Transplantation (FMT) |
| Standard Medical Treatment | Other | Standard Treatment Care |
Primary outcome
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
Time frame: 1 year
11 secondary outcomes
Improvement in liver function test as compared to baseline.
Time frame: 1 year
Improvement in Liver Stiffness Measurement as compared to baseline.
Time frame: 1 year
Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)
Time frame: 1 year
Incidence of new onset upper gastrointestinal bleed in both groups
Time frame: 1 year
development of new onset of ascites in both groups.
Time frame: 1 year
Number of Spontaneous Bacterial peritonitis cases in both groups.
Time frame: 1 year
ACLF (Acute on Chronic Liver failure) cases in both groups.
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups
Time frame: 1 year
Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.
Time frame: 1 year
Histological and permeability changes in the duodenal biopsy in both groups.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Derived from this study: PubMed 40568349Aghara H, Patel M, Chadha P, Parwani K, Chaturvedi R, Mandal P. Unraveling the Gut-Liver-Brain Axis: Microbiome, Inflammation, and Emerging Therapeutic Approaches. Mediators Inflamm. 2025 Jun 18;2025:6733477. doi: 10.1155/mi/6733477. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dr Abhinav Verma, MD 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 Transplant and Standard Medical Treatment in people with Non Alcoholic Steatohepatitis, 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 4 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: status not confirmed, as of the sponsor's last update on 15 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Abhinav Verma, MD (011-46300000, abhinav.3183@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline. (time frame: 1 year). 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 NCT02721264, 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 15 Feb 2018.