Hepatic Encephalopathy
Conditions
Keywords
Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose
Brief 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.
Interventions
DIETARY_SUPPLEMENTPolydextrose
PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.
Sponsors
Société nationale française de gastro-entérologie
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic encephalopathy incidence | 6 months | The primary outcome is the cumulative incidence (%) of hepatic encephalopathy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient with dose reduction | 6 months | compliance will be evaluated by the number of patient with a dose reduction or who stop the product |
| Adverse events | 6 months | safety will be evaluated by collection of adverse events |
Countries
France
Contacts
Primary ContactChristophe BUREAU, MD
Outcome results
None listed