Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Toulouse University Hospital
RECRUITING
Toulouse
Contact Information
Primary
Christophe BUREAU, MD
bureau.c@chu-toulouse.fr
05 61 32 2 686
Time Frame
Start Date: 2022-05-09
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Polydextrose
Patients will receive PDX 15 days prior and for a 6 month periods after TIPS.
Related Therapeutic Areas
Sponsors
Collaborators: Société nationale française de gastro-entérologie
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov