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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lactate Clearance After RIPC in Liver Resection

NCT05594641

Liver Surgery Remote Ischaemic Preconditioning

UNKNOWN NA

Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis

NCT05401383

EGDS Preparation; Fasting; Lumevis

UNKNOWN

Applying Long-term Follow-up to Improve Patient Selection in Laparoscopic Anti-reflux Surgery

NCT03959020

GERD Reflux, Gastroesophageal Surgery

COMPLETED

Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

NCT01321294

Gastroesophageal Reflux Disease Laparoscopic Antireflux Surgery

COMPLETED NA

Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease

NCT00453830

Diverticulitis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cirrhotic Patients Undergoing TIPS Placement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard

Group Type NO_INTERVENTION

No interventions assigned to this group

treatment

rifaximine and lattulose plus low proteine diet

Group Type EXPERIMENTAL

lattulose and rifaximine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lattulose and rifaximine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No