Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-01-01

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.

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Detailed Description

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Conditions

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Decompensated Cirrhosis Small Bowel Bacterial Overgrowth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomised, placebo-controlled study

Study Groups

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Control arm

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment arm

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

Rifaximin 1000mg OM

Interventions

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Rifaximin

Rifaximin 1000mg OM

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No