Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04775329

Acronym

SIBOC

Enrollment

Registered

2021-03-01

Start date

2020-11-01

Completion date

2023-01-01

Last updated

2023-01-06

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

Conditions

Decompensated Cirrhosis, Small Bowel Bacterial Overgrowth Syndrome

Keywords

Rifaximin

Brief summary

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.

Interventions

DRUGRifaximin

Rifaximin 1000mg OM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

Randomised, placebo-controlled study

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Spontaneous bacterial peritonitis	12 months	To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.

Secondary

Measure	Time frame	Description
Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)	12 months	To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers.

Countries

Singapore

Outcome results

None listed

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