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NCT02931123 Clinical Trial

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

Cirrhotic Patients Undergoing TIPS Placement Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02931123
Other study ID # OR-201
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received October 10, 2016
Last updated October 10, 2016
Start date November 2015
Est. completion date November 2018

Study information
Verified date October 2016
Source University of Roma La Sapienza
Contact Oliviero Riggio, Professor
Phone +390649972021
Email oliviero.riggio@uniroma1.it
Is FDA regulated No
Health authority Italy: AIFA
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 58
Est. completion date November 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• lattulose and rifaximine

Locations
Country Name City State
Italy Department of Clinical Medicine Rome RM

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of hepatic encephalopathy one month Yes