A RCT COMPARING LACTULOSE AND RIFAXIMIN ASSOCIATED WITH A VEGETABLE DIET IN THE PREVENTION OF POST-TIPS OVERT HEPATIC ENCEPHALOPATHY

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02931123

Enrollment

Registered

2016-10-12

Start date

2015-11-30

Completion date

2018-11-30

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhotic Patients Undergoing TIPS Placement

Brief summary

This is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-TIPS hepatic encephalopathy.

Interventions

DRUGlattulose and rifaximine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* consecutive cirrhotic patients undergoing TIPS

Exclusion criteria

* age \>75 years; bilirubin levels \>5 mg/dl; creatinine levels \>3 mg/dl; a serious cardiac or pulmonary dysfunction; a Child-Pugh's score \>11 (except for the patients candidates to early TIPS); a model end-stage liver disease (MELD) score \>18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. Present HE or previous spontaneous/recurrent HE, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state \< 26).

Design outcomes

Primary

Measure	Time frame
incidence of hepatic encephalopathy	one month

Countries

Italy

Contacts

Primary ContactOliviero Riggio, Professor

oliviero.riggio@uniroma1.it+390649972021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026