Primary Prophylaxis for Spontaneous Bacterial Peritonitis (SIBOC)

January 4, 2023 updated by: Changi General Hospital

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Wong Yu Jun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Standard of care
Active Comparator: Treatment arm
Drug: Rifaximin
Rifaximin 1000mg OM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: YU JUN WONG, MD, MRCP FAMS, Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

February 25, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIBOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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