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NCT06131177
Nutritional Interventions in Patients With Alcohol-associated Hepatitis
NA trial testing Nutritional supplement in Alcoholic Hepatitis in 2,000 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | Western University, Canada |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2,000 |
| Start date | 1 January 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- Nutritional supplement — full drug profile →
Conditions studied
- Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →
Sponsor
Western University, Canada
Who can join
18 and older, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Alcohol-associated hepatitis (AH) is a life-threatening condition with high 90-days mortality (up to 40%) and limited treatment options. Previous studies have shown that decreased nutritional intake (less than 21 kcal/kg/day) is associated to a higher mortality compared to patients with a higher caloric intake. Additionally, it has been suggested that subjects with severe AH, should receive a high-protein diet, however, no specific trials have been carried out to address these questions. Thus, the investigators aim to compare nutritional interventions through a randomized controlled trial to assess if a strategy of peripheral parental nutrition (PPN) plus oral nutritional supplementation (ONS) improves outcomes in patients with severe AH. The investigators will compare standard oral intake, enhanced oral intake with IV fluid supplementation, and PPN plus ONS in patients admitted to hospital with severe AH. These results potentially will help guide practitioners on caloric benchmarks targets for patients with severe AH. This study will also assess specific risks and benefits of different nutritional interventions.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current Clinical Trials for Alcohol-Associated Hepatitis.
Rady ED, Anouti A, Mitchell MC, Cotter TG. · · 2026 · cited 3× · PMID 40254132 · DOI 10.1016/j.ajpath.2025.03.009 -
Alcohol-Associated Hepatitis: Translating Pathophysiology into Targeted Clinical Trials.
Ma J, Gao H, Zeng G, Huda N, et al · · 2025 · PMID 41163775 · DOI 10.1007/s11901-025-00703-9
Verify or expand the search:
- PubMed search for NCT06131177
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Alcoholic Hepatitis
Currently open trials in the same condition.
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- NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
- NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
- NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting
Other Western University, Canada trials
Trials by the same sponsor.
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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 NCT06131177 (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 Western University, Canada
- Last refreshed: 29 May 2024
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/NCT06131177.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing