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

N/AUnknownNCT05206487

University Hospital, Toulouse30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

PolydextroseDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female at least 18 years of age * Affected (c) cirrhosis in which the establishment of a TIPS is scheduled within the month for: the treatment of ascites or a refractory hydrothorax or the prevention of the recurrence of a related digestive hemorrhage portal hypertension * Having signed the consent to participate in the study * Women of childbearing age on effective contraception * Affiliated to a social security scheme Exclusion Criteria: * Contraindication for TIPS * Digestive short circuit, chronic inflammatory bowel diseases * Indications of TIPS in emergency or as part of the preparation for a surgical procedure, * Liver transplant, * Patient for whom the follow-up is considered impossible due to non-compliance with care or because the vital prognosis is estimated less than 6 months because of an incurable chronic pathology, * Pregnant or lactating women, * Those unable to receive enlightened information, * Those participating in another interventional research including an exclusion period * Persons placed under safeguard of justice, tutelage or curators.

Locations (1)

Toulouse University Hospital

Toulouse, France

RECRUITING

Outcomes

Primary Outcomes

Hepatic encephalopathy incidence

The primary outcome is the cumulative incidence (%) of hepatic encephalopathy

Time frame: 6 months

Secondary Outcomes

Number of patient with dose reduction

compliance will be evaluated by the number of patient with a dose reduction or who stop the product

Time frame: 6 months

Adverse events

safety will be evaluated by collection of adverse events

Time frame: 6 months

Central Contacts

Christophe BUREAU, MD

CONTACT

05 61 32 2 686 bureau.c@chu-toulouse.fr

Data from ClinicalTrials.gov

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