Last reviewed · How we verify
NCT02721264
Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.
NA trial testing Fecal Microbiota Transplant in Non Alcoholic Steatohepatitis in 112 participants. Status unknown.
30 June 2018
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 1 March 2016 |
| Primary completion | 30 June 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across India |
Drugs / interventions tested
- Fecal Microbiota Transplant — full drug profile →
- Standard Medical Treatment — full drug profile →
Conditions studied
- Non Alcoholic Steatohepatitis — all drugs for Non Alcoholic Steatohepatitis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 75, any sex, with Non Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Gut Microbiota Metabolites in NAFLD Pathogenesis and Therapeutic Implications.
Chen J, Vitetta L. · · 2020 · cited 235× · PMID 32717871 · DOI 10.3390/ijms21155214 -
Intestinal microbiome and NAFLD: molecular insights and therapeutic perspectives.
Hu H, Lin A, Kong M, Yao X, et al · · 2020 · cited 142× · PMID 31845054 · DOI 10.1007/s00535-019-01649-8 -
Fecal microbiota transplantation beyond Clostridioides difficile infections.
Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066 -
Inflammatory Mechanisms Underlying Nonalcoholic Steatohepatitis and the Transition to Hepatocellular Carcinoma.
Peiseler M, Tacke F. · · 2021 · cited 53× · PMID 33578800 · DOI 10.3390/cancers13040730 -
Advances in Fecal Microbiota Transplantation for Gut Dysbiosis-Related Diseases.
Hou S, Yu J, Li Y, Zhao D, et al · · 2025 · cited 34× · PMID 40013938 · DOI 10.1002/advs.202413197 -
Fecal Microbiota Transplantation in NAFLD Treatment.
Abenavoli L, Maurizi V, Rinninella E, Tack J, et al · · 2022 · cited 31× · PMID 36363516 · DOI 10.3390/medicina58111559 -
Gut microbiota and their metabolites in the progression of non-alcoholic fatty liver disease.
Zhou J, Tripathi M, Sinha RA, Singh BK, et al · · 2021 · cited 28× · PMID 33490737 · DOI 10.20517/2394-5079.2020.134 -
Modulating the Intestinal Microbiota: Therapeutic Opportunities in Liver Disease.
Philips CA, Augustine P, Yerol PK, Ramesh GN, et al · · 2020 · cited 27× · PMID 32274349 · DOI 10.14218/jcth.2019.00035
Verify or expand the search:
- PubMed search for NCT02721264
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fecal Microbiota Transplant
Trials testing the same drug.
- NCT05967871 — Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth · Phase 1 · recruiting
- NCT05229289 — Efficacy and Safety of Fecal Microbiota Transplant for Secondary Prophylaxis of Hepatic Encephalopathy · NA · unknown
- NCT04139577 — FMT In High-Risk Acute GVHD After ALLO HCT · Phase 1 · completed
- NCT03363022 — To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure · NA · withdrawn
- NCT03998423 — Oral Fecal Microbiota Transplant Feasibility Study in Alzheimer's Disease · Phase 1 · terminated
Other recruiting trials for Non Alcoholic Steatohepatitis
Currently open trials in the same condition.
- NCT06676813 — Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis. · NA · recruiting
- NCT05463796 — InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer · recruiting
- NCT05821010 — Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis · Phase 2 · recruiting
- NCT05574036 — Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia · Phase 2 · active not recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02721264 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 15 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02721264.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing