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Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)

NCT05206487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-30

No results posted yet for this study

Summary

TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiology of HE.

Polydextrose (PDX) is consider as a prebiotic. Preliminary studies showed that PDX:

1. modified gut microbiota, enhancing "good bacteria"
2. improved gut permeability and immunity in 2 experimental models: infarction and colitis.

The aim of this study is to assess PDX efficacy to prevent HE during the first 6 months after TIPS in cirrhotic patients.

Conditions

  • Hepatic Encephalopathy

Interventions

DIETARY_SUPPLEMENT

Polydextrose

PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

Sponsors & Collaborators

  • Société nationale française de gastro-entérologie

    collaborator UNKNOWN

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Christophe BUREAU, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • France

Study Locations

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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 NCT05206487 on ClinicalTrials.gov