Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Phase 2

Terminated

• Conditions: Small Bowel Bacterial Overgrowth Syndrome; Decompensated Cirrhosis
• Interventions: Drug: Rifaximin

• Registration Number: NCT04775329
• Lead Sponsor: Changi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	Rifaximin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wong Yu Jun; 🇸🇬 Singapore, Singapore