NCT05206487

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. 1.modified gut microbiota, enhancing "good bacteria"
  2. 2.improved gut permeability and immunity in 2 experimental models: infarction and colitis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

3.1 years

First QC Date

January 11, 2022

Last Update Submit

April 29, 2024

Conditions

Hepatic Encephalopathy

Keywords

Hepatic EncephalopathyTIPSMicrobiotaPolydextrose

Outcome Measures

Primary Outcomes (1)

  • Hepatic encephalopathy incidence

    The primary outcome is the cumulative incidence (%) of hepatic encephalopathy

    6 months

Secondary Outcomes (2)

  • Number of patient with dose reduction

    6 months

  • Adverse events

    6 months

Study Arms (1)

Polydextrose

EXPERIMENTAL

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

Dietary Supplement: Polydextrose

Interventions

PolydextroseDIETARY_SUPPLEMENT

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

Polydextrose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • Persons placed under safeguard of justice, tutelage or curators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, 31059, France

RECRUITING

Related Publications (3)

  • Bureau C, Metivier S, D'Amico M, Peron JM, Otal P, Pagan JC, Chabbert V, Chagneau-Derrode C, Procopet B, Rousseau H, Bosch J, Vinel JP. Serum bilirubin and platelet count: a simple predictive model for survival in patients with refractory ascites treated by TIPS. J Hepatol. 2011 May;54(5):901-7. doi: 10.1016/j.jhep.2010.08.025. Epub 2011 Feb 18.

    PMID: 21145798BACKGROUND

  • European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available.

    PMID: 29653741BACKGROUND

  • Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Peron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20.

    PMID: 27663604BACKGROUND

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

polydextrose

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Christophe BUREAU, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe BUREAU, MD

CONTACT

05 61 32 2 686bureau.c@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

May 9, 2022

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)