NCT04155099

Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy

Terminated Phase 2 Last updated 3 October 2023

What this trial tests

Phase 2 trial testing RBX7455 in Hepatic Encephalopathy in 5 participants. Terminated before completion.

Timeline

1 March 2021

Primary endpoint
30 July 2023

30 July 2023

Quick facts

Lead sponsor	Ochsner Health System
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	1 March 2021
Primary completion	30 July 2023
Estimated completion	30 July 2023
Sites	1 location across United States

Drugs / interventions tested

• RBX7455 — full drug profile →
• Placebo

Conditions studied

• Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →
• Cirrhosis, Liver — all drugs for Cirrhosis, Liver →

Sponsor

Ochsner Health System — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Encephalopathy or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
2. 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
3. The Urgent Threat of <i>Clostridioides difficile</i> Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects.
   Alshrari AS, Hudu SA, Elmigdadi F, Imran M. · · 2023 · cited 17× · PMID 36830964 · DOI 10.3390/biomedicines11020426
4. Active Clinical Trials in Hepatic Encephalopathy: Something Old, Something New and Something Borrowed.
   Balzano T. · · 2023 · cited 6× · PMID 36977964 · DOI 10.1007/s11064-023-03916-w
5. Future Therapies of Hepatic Encephalopathy.
   Buckholz AP, Brown RS. · · 2024 · cited 5× · PMID 38548443 · DOI 10.1016/j.cld.2024.02.002
6. Genome-scale metabolic model-guided systematic framework for designing customized live biotherapeutic products.
   Lee YQ, Choi YM, Park SY, Kim SK, et al · · 2025 · cited 2× · PMID 40624071 · DOI 10.1038/s41540-025-00555-5
7. Current progress on the microbial therapies for acute liver failure.
   Huang J, Xu T, Quan G, Li Y, et al · · 2024 · PMID 39479215 · DOI 10.3389/fmicb.2024.1452663