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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Polydextrose

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

Group Type EXPERIMENTAL

Polydextrose

Intervention Type DIETARY_SUPPLEMENT

PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

Interventions

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Polydextrose

PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No