Hepatic EncephalopathyPOEMENCT05206487
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)
A study testing Polydextrose in people with Hepatic Encephalopathy, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Polydextrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Toulouse University Hospital
Toulouse, 31059
Christophe BUREAU, PH, 0561322686 ext. +33, bureau.c@chu-toulouse.fr
Christophe BUREAU, PH
About this study
Official title: Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
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:
- modified gut microbiota, enhancing "good bacteria"
- 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.
Read the 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:
- modified gut microbiota, enhancing "good bacteria"
- 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.
- Conditions
- Hepatic Encephalopathy
- Being tested
- Polydextrose
- Keywords
- Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolydextroseDietary supplement
PDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS.
| Study group | Role | What they receive |
|---|---|---|
| Polydextrose | Experimental | Patients will receive PDX 15 days prior and for a 6 month periods after TIPS. Receives: Dietary Supplement: Polydextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic encephalopathy incidence
The primary outcome is the cumulative incidence (%) of hepatic encephalopathy
Measured: 6 months
Secondary outcomes (2)
Number of patient with dose reduction
compliance will be evaluated by the number of patient with a dose reduction or who stop the product
Measured: 6 months
Adverse events
safety will be evaluated by collection of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start9 May 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Responsible party
- Sponsor
- Investigators
- Christophe BUREAU, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206487
- Sponsor's protocol ID
- RC31/19/0493
- Other IDs
- 2020-A01217-32
- Acronym
- POEME
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21145798European 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.
PubMed 29653741Bureau 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.
PubMed 27663604
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study
- ClinicalTrials.gov ID
- NCT05206487
- Acronym / sponsor ID
- POEME / RC31/19/0493
- Conditions
- Hepatic Encephalopathy
- Keywords
- Hepatic Encephalopathy, TIPS, Microbiota, Polydextrose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Société Nationale Française de Gastroentérologie
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- modified gut microbiota, enhancing "good bacteria"
- 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:
- modified gut microbiota, enhancing "good bacteria"
- 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polydextrose | Experimental | Dietary Supplement: PolydextrosePatients will receive PDX 15 days prior and for a 6 month periods after TIPS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolydextrosePDX will be started 2 weeks before TIPS and taken daily for a 6 month period after TIPS. | Dietary supplement | Polydextrose |
Primary outcome
Hepatic encephalopathy incidence
Time frame: 6 months
The primary outcome is the cumulative incidence (%) of hepatic encephalopathy
2 secondary outcomes
Number of patient with dose reduction
Time frame: 6 months
Adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Background: PubMed 21145798Bureau 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.
- Background: PubMed 29653741European 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.
- Background: PubMed 27663604Bureau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe BUREAU, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose in people with Hepatic Encephalopathy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe BUREAU, MD (05 61 32 2 686 ext. +33, bureau.c@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic encephalopathy incidence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206487, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.