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Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes

NCT06630572 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-08

No results posted yet for this study

Summary

Rifaximin is an antibiotic that acts locally in the gastrointestinal tract with a broad spectrum of antibacterial activity. The efficacy of rifaximin is well documented in the prevention of acute hepatic encephalopathy. There is no evidence on its benefit to modulate hypercoagulative state in cirrhotic patient.

To assess the effect of a short-term treatment with rifaximin on systemic levels of intestinal endotoxin and on platelet and coagulation markers in patients with decompensated cirrhosis the study has been planned.

Conditions

Interventions

DRUG

Rifaximin

Patients randomized to receive Rifaximin for 14 days

DRUG

Placebo

Patients randomized to receive Placebo for 14 days

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Stefania BASILI, Prof. · SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

  • Oliviero Riggio, Prof. · SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

  • Manuela Merli, Prof. · SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

  • Lucia Stefanini, Prof. · SAPIENZA UNIVERSITY- Department of Translational and Precision Medicine

  • Roberto Carnevale, Prof. · SAPIENZA UNIVERSITY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-03
Primary Completion
2022-04-03
Completion
2024-08-01

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630572 on ClinicalTrials.gov