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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jan 11, 2022

Keywords

ClinConnect Summary

The POEME trial is studying whether a substance called polydextrose (PDX) can help prevent a serious liver-related condition known as hepatic encephalopathy (HE) in patients who have undergone a procedure called TIPS. TIPS is used to treat complications from high blood pressure in the liver, but about 40% of patients still experience HE in the first year after the procedure. Researchers believe that PDX, which is considered a prebiotic and may help improve the balance of good bacteria in the gut, could play a role in preventing HE during the first six months after TIPS.

To be eligible for this study, participants must be adults aged 18 or older with cirrhosis who are scheduled to have a TIPS procedure within the next month. They should not have any contraindications for TIPS or certain digestive conditions. Participants will be asked to sign consent to join the study and, if applicable, use effective contraception if they are women of childbearing age. Those who join the trial can expect to receive either PDX or a placebo and will be monitored for six months to see if PDX helps reduce the risk of developing HE. This study aims to gather valuable information that could improve care for patients with liver problems in the future.

Gender

ALL

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.