Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Phase 3TerminatedNCT04775329

Changi General Hospital2 enrolled

Overview

Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Decompensated Cirrhosis Small Bowel Bacterial Overgrowth Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Decompensated liver cirrhosis (Childs B \& C) with ascites. * Established diagnosis of SIBO Exclusion Criteria: * Known allergy to treatment drugs * Inability to undergo test confirm the success of SIBO eradication; * Pregnant or lactating women * Terminal malignancy. * Untreated Viral Hepatitis * Alcoholic Liver disease with ongoing drinking. * Respiratory Failure * Recent antibiotics and proton-pump inhibitor within 30 days

Outcomes

Primary Outcomes

Incidence of Spontaneous bacterial peritonitis

To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.

Time frame: 12 months

Secondary Outcomes

Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)

To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers.