NCT02721264

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

March 1, 2016

Last Update Submit

February 13, 2018

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

  • Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.

    1 year

Secondary Outcomes (11)

  • Improvement in liver function test as compared to baseline.

    1 year

  • Improvement in Liver Stiffness Measurement as compared to baseline.

    1 year

  • Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)

    1 year

  • Incidence of new onset upper gastrointestinal bleed in both groups

    1 year

  • development of new onset of ascites in both groups.

    1 year

  • +6 more secondary outcomes

Study Arms (2)

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.

Biological: Fecal Microbiota Transplant

Standard Treatment Care

ACTIVE COMPARATOR
Other: Standard Medical Treatment

Interventions

Fecal Microbiota TransplantBIOLOGICAL
Fecal Microbiota Transplantation (FMT)
Standard Medical TreatmentOTHER
Standard Treatment Care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Psychiatric disorder
  • HIV
  • Pregnant women
  • Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40568349DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Dr Abhinav Verma, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Abhinav Verma, MD

CONTACT

011-46300000abhinav.3183@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 29, 2016

Study Start

March 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

February 15, 2018

Record last verified: 2018-02

Locations

IN(1)