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

Hepatic Encephalopathy Clinical Trial

— POEME  

Official title:

Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206487
• Other study ID #: RC31/19/0493
• Secondary ID: 2020-A01217-32
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Toulouse
• Contact: Christophe BUREAU, MD
• Phone: 05 61 32 2 686
• Email: bureau.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Dietary Supplement:
• Polydextrose
PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Société nationale française de gastro-entérologie

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. Erratum In: Gastroenterology. 2017 Sep;153(3):870. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic encephalopathy incidence	The primary outcome is the cumulative incidence (%) of hepatic encephalopathy	6 months
Secondary	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
Secondary	Adverse events	safety will be evaluated by collection of adverse events	6 months