NCT05206487

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

Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients will receive PDX 15 days prior to and 6 months after TIPS. We will assess the cumulative incidence of HE 6 months after TIPS. Patients will be followed-up for 12 months after TIPS.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Polydextrose	PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

Timeline

• Start date: 2022-05-09
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2022-01-25
• Last updated: 2024-04-30

Locations

1 site across 1 country: France