Hepatic Encephalopathy Prevention With Polydextrose After... | NCT05206487

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

NCT05206487

Sponsor

University Hospital, Toulouse

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Hepatic Encephalopathy

Interventions

Polydextrose

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01217-32	Other Identifier	ID-RCB

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2022Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Jan 11, 2022

First Submission Date that Met QC Criteria

Jan 11, 2022

First Posted Date

Jan 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2024

Last Update Posted Date

Apr 30, 2024Actual

Name	Class
Société Nationale Française de Gastroentérologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polydextrose	Experimental	Patients will receive PDX 15 days prior and for a 6 month periods after TIPS.	Dietary Supplement: Polydextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polydextrose	Dietary Supplement	PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.	Polydextrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hepatic encephalopathy incidence	The primary outcome is the cumulative incidence (%) of hepatic encephalopathy	6 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe BUREAU, MD	Contact	05 61 32 2 686	+33	bureau.c@chu-toulouse.fr

Overall Officials

Name	Affiliation	Role
Christophe BUREAU, MD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toulouse University Hospital	Recruiting	Toulouse		31059	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21145798	Background	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.
29653741

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases