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

Study Overview
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Brief Summary
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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: modified gut microbiota, enhancing good bacteria 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
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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: modified gut microbiota, enhancing good bacteria 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.

Official Title
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Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Dietary Supplement: Polydextrose


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polydextrose<br>Patients will receive PDX 15 days prior and for a 6 month periods after TIPS. | Dietary Supplement: Polydextrose<br>* PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic encephalopathy incidence | The primary outcome is the cumulative incidence (%) of hepatic encephalopathy | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with dose reduction | compliance will be evaluated by the number of patient with a dose reduction or who stop the product | 6 months | 
| Adverse events | safety will be evaluated by collection of adverse events | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose