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

Toulouse University Hospital

Status: Enrolling

Conditions: Hepatic Encephalopathy

Treatments: Dietary Supplement: Polydextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT05206487

2020-A01217-32 (Other Identifier)

RC31/19/0493

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Polydextrose

Experimental group

Description:

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

Treatment:

Dietary Supplement: Polydextrose