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NCT03363022
To Assess the Role of Fecal Microbiota Transplant in Acute Liver Failure
NA trial testing Standard Medical Treatment in Acute Liver Failure. Withdrawn.
31 December 2020
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 February 2020 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across India |
Drugs / interventions tested
- Standard Medical Treatment — full drug profile →
- Fecal Microbiota Transplant — full drug profile →
- Placebo
Conditions studied
- Acute Liver Failure — all drugs for Acute Liver Failure →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 65, any sex, with Acute Liver Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
All patients of Acute liver failure not meeting the KCH (King's College Hospital) criteria/or meeting KCH criteria not having option of liver transplant will be recruited for the trial. The first group will receive Standard medical care with Fecal Microbiota transplant on Day 1 for 3 consecutive days. FMT (Fecal Microbiota Transplant) will be delivered rectally which will be placed bedside. Suitable donor will be screened and the stool samples will be used as per criteria. Stool samples will be taken at the time at Day 0, 1(Post FMT), Day 4, 6, 14,21. Sepsis screen will be sent. Inflammatory markers will be sent on Day 0,1, 4,6, 14,21. The second group will receive standard medical therapy/and an placebo. Stool samples will be sent on Day 0,1, 4, 6 , 14,21. Inflammatory markers will be sent on the time on day 0,1 4,6 , 14,21.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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
Verify or expand the search:
- PubMed search for NCT03363022
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Acute Liver Failure
Currently open trials in the same condition.
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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
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- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
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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 NCT03363022 (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: 5 November 2019
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/NCT03363022.
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