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

Not Applicable

Recruiting

• Conditions: Hepatic Encephalopathy
• Interventions: Dietary Supplement: Polydextrose

• Registration Number: NCT05206487
• Lead Sponsor: University Hospital, Toulouse

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:

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.

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:

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.

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-05-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hepatic encephalopathy incidence	6 months	The primary outcome is the cumulative incidence (%) of hepatic encephalopathy

Secondary Outcome Measures

Name	Time	Method
Number of patient with dose reduction	6 months	compliance will be evaluated by the number of patient with a dose reduction or who stop the product
Adverse events	6 months	safety will be evaluated by collection of adverse events

Trial Locations

Locations (1)

Toulouse University Hospital; 🇫🇷 Toulouse, France