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NCT02255617
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Phase 1, PHASE2 trial testing Fecal Microbiota Transplant in Hepatic Encephalopathy in 4 participants. Completed in 23 September 2019.
25 July 2019
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 4 |
| Start date | 23 July 2014 |
| Primary completion | 25 July 2019 |
| Estimated completion | 23 September 2019 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Fecal Microbiota Transplant — full drug profile →
Conditions studied
- Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →
Sponsor
University of Alberta
Who can join
Adults 18 to 65, any sex, with Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Hepatic encephalopathy: a critical current review.
Hadjihambi A, Arias N, Sheikh M, Jalan R. · · 2018 · cited 131× · PMID 28770516 · DOI 10.1007/s12072-017-9812-3 -
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 -
Fecal Microbiota Transplantation: A New Therapeutic Attempt from the Gut to the Brain.
Xu HM, Huang HL, Zhou YL, Zhao HL, et al · · 2021 · cited 59× · PMID 33510784 · DOI 10.1155/2021/6699268 -
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 -
Gut microbiota mediated molecular events and therapy in liver diseases.
Qi X, Yang M, Stenberg J, Dey R, et al · · 2020 · cited 20× · PMID 33505139 · DOI 10.3748/wjg.v26.i48.7603 -
Gut microbiome and liver diseases.
Xu J, Chen N, Li Z, Liu Y. · · 2025 · cited 6× · PMID 40242515 · DOI 10.1016/j.fmre.2024.09.007 -
Modulating the microbiome in chronic liver diseases - current evidence on the role of fecal microbiota transplantation.
Saha S, Schnabl B. · · 2025 · cited 6× · PMID 39760535 · DOI 10.1080/17474124.2025.2450707 -
Hepatic encephalopathy: New treatments.
Hadjihambi A, Jalan R. · · 2015 · cited 6× · PMID 31040962 · DOI 10.1002/cld.468
Verify or expand the search:
- PubMed search for NCT02255617
- 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 Hepatic Encephalopathy
Currently open trials in the same condition.
- NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT06953921 — Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in · recruiting
- NCT07437638 — Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liv · active not recruiting
- NCT06425380 — Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy · NA · recruiting
Other University of Alberta trials
Trials by the same sponsor.
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- NCT04231760 — The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD · Phase 1, PHASE2 · not yet recruiting
- NCT06649604 — Reducing Pain From Retinal Laser With Vibrational Stimulation · NA · not yet recruiting
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT06920914 — Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD · 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 NCT02255617 (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 University of Alberta
- Last refreshed: 4 October 2021
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/NCT02255617.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing