Suspended

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

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What is being tested

Rifaximin

Drug
Who is being recruted

From 18 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2 & 3
Interventional
Study Start: November 2020
See protocol details

Summary

Principal SponsorChangi General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2020

Actual date on which the first participant was enrolled.

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.

Official TitlePrimary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
Principal SponsorChangi General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Decompensated liver cirrhosis (Childs B & C) with ascites.

Established diagnosis of SIBO

8 exclusion criteria prevent from participating
Terminal malignancy.

Respiratory Failure

Untreated Viral Hepatitis

Alcoholic Liver disease with ongoing drinking.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Wong Yu Jun

Singapore, SingaporeOpen Wong Yu Jun in Google Maps
SuspendedOne Study Center