NCT04775329

Primary Prophylaxis for Spontaneous Bacterial Peritonitis

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Changi General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Decompensated Cirrhosis
• Small Bowel Bacterial Overgrowth Syndrome

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin 1000mg OM

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2021-03-01
• Last updated: 2023-01-06

Locations

1 site across 1 country: Singapore