Liver patients get brain protection: antibiotic may stop confusion after TIPS
NCT ID NCT02016196
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether the antibiotic rifaximin could prevent a serious brain condition called hepatic encephalopathy in people with cirrhosis who undergo a TIPS procedure. The TIPS procedure helps reduce pressure in the liver but often leads to confusion and other brain issues. The trial involved 211 participants and compared rifaximin to a placebo to see if it could lower the risk of these brain complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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211 people
The number who actually took part.
- Started
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Sep 2013
- Finished
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Jul 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * cirrhosis with TIPS for ascit treatment or hydrothorax * prevention digestive bleeding follow up portal hypertension - * signed consent Exclusion Criteria: * hepatocellular carcinoma out of Milan criteria or palliative phase cancer * Child Pugh score \> 12 * TIPS indicated for other indication than bellow * encephalopathy signs : asterixis or confusion * Hypersensibility to rifaximin, or derivated of rifamycin * Patients treated by same class antibacterial * pregnant woman * Patient with hepatic transplant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHRU Lille
Lille, France
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CHU Angers
Angers, France
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CHU Beaujon Clichy
Paris, France
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CHU Bordeaux
Bordeaux, France
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CHU Marseille
Marseille, France
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CHU Nantes
Nantes, France
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CHU Poitiers
Poitiers, France
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CHU Rennes
Rennes, France
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CHU Saint-Antoine
Paris, France
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CHU Tours
Tours, France
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Hôpital Jean Verdier
Bondy, France
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Pitié Salpêtrière
Paris, France
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UHToulouse
Toulouse, France, 31059, France
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Other studies related to the condition(s) this trial covers.
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