Clinical trial NCT05206487: Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)
Official title: Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
TIPS
Microbiota
Polydextrose
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Société nationale française de gastro-entérologie
First posted: 2022-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hepatic encephalopathy incidence
timeFrame: 6 months
Secondary outcomes:
measure: Number of patient with dose reduction
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Christophe BUREAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bureau C, Metivier S, D'Amico M, Peron JM, Otal P, Pagan JC, Chabbert V, Chagneau-Derrode C, Procopet B, Rousseau H, Bosch J, Vinel JP. Serum bilirubin and platelet count: a simple predictive model for survival in patients with refractory ascites treated by TIPS. J Hepatol. 2011 May;54(5):901-7. doi: 10.1016/j.jhep.2010.08.025. Epub 2011 Feb 18.
citation: European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.
citation: Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20.