Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
University Hospital, Toulouse
30 participants
May 9, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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.
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Interventions
PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.
Locations(1)
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NCT05206487