Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Decompensated Cirrhosis Clinical Trial

— SIBOC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04775329
• Other study ID #: SIBOC
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: November 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Decompensated Cirrhosis
• Peritonitis
• Small Bowel Bacterial Overgrowth Syndrome

Intervention

Drug:
• Rifaximin
Rifaximin 1000mg OM

Locations

Country	Name	City	State
Singapore	Wong Yu Jun	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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