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

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polydextrose
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toulouse University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polydextrose

Arm Description

Patients will receive PDX 15 days prior and for a 6 month periods after TIPS.

Outcomes

Primary Outcome Measures

Hepatic encephalopathy incidence
The primary outcome is the cumulative incidence (%) of hepatic encephalopathy

Secondary Outcome Measures

Number of patient with dose reduction
compliance will be evaluated by the number of patient with a dose reduction or who stop the product
Adverse events
safety will be evaluated by collection of adverse events

Full Information

First Posted
January 11, 2022
Last Updated
April 20, 2023
Sponsor
University Hospital, Toulouse
Collaborators
Société nationale française de gastro-entérologie
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1. Study Identification

Unique Protocol Identification Number
NCT05206487
Brief Title
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)
Acronym
POEME
Official Title
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Société nationale française de gastro-entérologie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: modified gut microbiota, enhancing "good bacteria" 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: modified gut microbiota, enhancing "good bacteria" 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Polydextrose
Arm Type
Experimental
Arm Description
Patients will receive PDX 15 days prior and for a 6 month periods after TIPS.
Intervention Type
Dietary Supplement
Intervention Name(s)
Polydextrose
Intervention Description
PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.
Primary Outcome Measure Information:
Title
Hepatic encephalopathy incidence
Description
The primary outcome is the cumulative incidence (%) of hepatic encephalopathy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of patient with dose reduction
Description
compliance will be evaluated by the number of patient with a dose reduction or who stop the product
Time Frame
6 months
Title
Adverse events
Description
safety will be evaluated by collection of adverse events
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe BUREAU, MD
Phone
05 61 32 2 686
Ext
+33
Email
bureau.c@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, MD
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, PH
Phone
0561322686
Ext
+33
Email
bureau.c@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Christophe BUREAU, PH

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21145798
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.
Results Reference
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PubMed Identifier
29653741
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.
Results Reference
background
PubMed Identifier
27663604
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.
Results Reference
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Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)

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