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

Recruiting
18 - 70 years of age
Both
Phase N/A

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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.

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.

Eligibility

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.

Study details

Hepatic Encephalopathy

NCT05206487

University Hospital, Toulouse

16 May 2024

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