Primary Prophylaxis for Spontaneous Bacterial Peritonitis (SIBOC)

Changi General Hospital

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Decompensated Cirrhosis; Small Bowel Bacterial Overgrowth Syndrome

Treatments: Drug: Rifaximin

Study type: Interventional

Funder types: Other

Identifiers

NCT04775329

SIBOC

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2 participants in 2 patient groups

Control arm

No Intervention group

Description:

Standard of care

Treatment arm

Active Comparator group

Treatment:

Drug: Rifaximin