|

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

RECRUITINGN/ASponsored by University Hospital, Toulouse
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Toulouse
Started2022-05-09
Est. completion2025-06-30
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

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

Age: 18 Years – 70 YearsHealthy volunteers accepted
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.

Conditions2

Hepatic EncephalopathyLiver Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.