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

Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatic Encephalopathy
• Intervention / Treatment: Dietary supplement: Polydextrose

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe BUREAU, MD; Phone Number: +33 05 61 32 2 686; Email: bureau.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Toulouse University Hospital
    • Contact: Christophe BUREAU, PH; Phone Number: +33 0561322686; Email: bureau.c@chu-toulouse.fr
    • Principal Investigator: Christophe BUREAU, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polydextrose; Patients will receive PDX 15 days prior and for a 6 month periods after TIPS.	Dietary supplement: Polydextrose; PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Société nationale française de gastro-entérologie
• Investigators: Principal Investigator: Christophe BUREAU, MD, Toulouse University Hospital

Publications and helpful links

General Publications

• European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; 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. Erratum In: J Hepatol. 2018 Nov;69(5):1207.
• 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.
• 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. Erratum In: Gastroenterology. 2017 Sep;153(3):870.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Microbiota; TIPS; Hepatic Encephalopathy; Polydextrose
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Liver Diseases; Brain Diseases, Metabolic; Hepatic Encephalopathy; Brain Diseases
• Other Study ID Numbers: RC31/19/0493; 2020-A01217-32 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No