Preventing hepatic encephalopathy with polydextrose after TIPS
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
This study is testing if a prebiotic called polydextrose can help prevent brain problems in liver disease patients who are having a specific procedure called TIPS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05206487 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the efficacy of polydextrose, a prebiotic, in preventing hepatic encephalopathy (HE) in cirrhotic patients undergoing transjugular intrahepatic portosystemic shunt (TIPS) procedures. Patients will receive polydextrose for 15 days prior to and for 6 months following the TIPS procedure. The study will assess the cumulative incidence of HE over a 6-month period post-TIPS, with follow-up extending to 12 months. The research focuses on the role of gut microbiota in the pathophysiology of HE and aims to improve patient outcomes through microbiota modulation.
Who should consider this trial
Good fit: Ideal candidates include adults with cirrhosis scheduled for a TIPS procedure to manage complications related to portal hypertension.
Not a fit: Patients who have contraindications for TIPS or those with chronic inflammatory bowel diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hepatic encephalopathy in patients undergoing TIPS.
How similar studies have performed: Preliminary studies have shown promise in using polydextrose to modify gut microbiota and improve gut health, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- Toulouse University Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Christophe BUREAU, MD — University Hospital, Toulouse
- Study coordinator: Christophe BUREAU, MD
- Email: bureau.c@chu-toulouse.fr
- Phone: 05 61 32 2 686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.