NCT03467282: NASH

Probiotics in NASH Patients - PROBILIVER TRIAL

Status unknown NA Last updated 19 June 2020

What this trial tests

NA trial testing Probiotic in Non-Alcoholic Fatty Liver Disease in 46 participants. Status unknown.

Timeline

29 November 2017

Primary endpoint
31 July 2020

20 December 2021

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	29 November 2017
Primary completion	31 July 2020
Estimated completion	20 December 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Probiotic
• Placebo

Conditions studied

• Non-Alcoholic Fatty Liver Disease — all drugs for Non-Alcoholic Fatty Liver Disease →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 18 to 80, any sex, with Non-Alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-alcoholic Fatty Liver Disease (NAFLD) is characterized by excessive accumulation of lipids in hepatocytes, not associated with alcohol consumption and ranges from hepatic steatosis to steatohepatitis, a form that can progress to cirrhosis or hepatocarcinoma, and is considered a liver manifestation of the metabolic syndrome (MetS). The disease occurs in 16 - 30% of the general population, but can reach up to 90% of obese individuals. Changes in lifestyle, including weight loss and physical activity are indicated with first choices for improvement of the liver condition.

Recently the relationship between obesity, diabetes, MetS and NAFLD with intestinal microbiota has also been suggested in the development and progression of liver disease, since it is related to hepatic steatosis and inflammation. In this sense, this work aims to evaluate the effects of probiotic supplementation on intestinal microbiota modulation, degree of hepatic fibrosis and steatosis, inflammation and body composition.

Publications & conference data

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

1. Gut liver brain axis in diseases: the implications for therapeutic interventions.
   Yan M, Man S, Sun B, Ma L, et al · · 2023 · cited 165× · PMID 38057297 · DOI 10.1038/s41392-023-01673-4
2. The role of the gut microbiome in chronic liver disease: the clinical evidence revised.
   Schwenger KJ, Clermont-Dejean N, Allard JP. · · 2019 · cited 99× · PMID 32039372 · DOI 10.1016/j.jhepr.2019.04.004
3. The Role of Probiotics in Nonalcoholic Fatty Liver Disease: A New Insight into Therapeutic Strategies.
   Meroni M, Longo M, Dongiovanni P. · · 2019 · cited 96× · PMID 31689910 · DOI 10.3390/nu11112642
4. 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
5. Recent advances in therapeutic probiotics: insights from human trials.
   Cho M-Y, Eom J-H, Choi E-M, Yang S-J, et al · · 2025 · cited 17× · PMID 40261032 · DOI 10.1128/cmr.00240-24
6. Oral 24-week probiotics supplementation did not decrease cardiovascular risk markers in patients with biopsy proven NASH: A double-blind placebo-controlled randomized study.
   Barcelos STA, Silva-Sperb AS, Moraes HA, Longo L, et al · · 2023 · cited 15× · PMID 36216309 · DOI 10.1016/j.aohep.2022.100769
7. NAFLD and NAFLD Related HCC: Emerging Treatments and Clinical Trials.
   Khare T, Liu K, Chilambe LO, Khare S. · · 2025 · cited 12× · PMID 39796162 · DOI 10.3390/ijms26010306
8. Probiotic supplementation for 24 weeks in patients with non-alcoholic steatohepatitis: the PROBILIVER randomized clinical trial.
   Silva-Sperb AS, Moraes HA, Barcelos STA, de Moura BC, et al · · 2024 · cited 12× · PMID 38600992 · DOI 10.3389/fnut.2024.1362694