Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Study Overview
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Brief Summary
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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 Title
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Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial

Conditions
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Decompensated Cirrhosis, Small Bowel Bacterial Overgrowth Syndrome

Intervention / Treatment
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* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Standard of care | |
| Active Comparator: Treatment arm<br> | Drug: Rifaximin<br>* Rifaximin 1000mg OM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Spontaneous bacterial peritonitis | 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) | To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifaximin