Primary Prophylaxis for Spontaneous Bacterial Peritonitis

NCT04775329 | Terminated Phase 2 DMC

• 1 other identifier: SIBOC
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Decompensated Cirrhosis; Small Bowel Bacterial Overgrowth Syndrome

Keywords

Rifaximin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)

  12 months

Study Arms (2)

Control arm

NO INTERVENTION

Standard of care

Treatment arm

ACTIVE COMPARATOR

Drug: Rifaximin

Interventions

Rifaximin DRUG

Rifaximin 1000mg OM

Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompensated liver cirrhosis (Childs B \& C) with ascites.
• Established diagnosis of SIBO

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Wong Yu Jun

Singapore, 529889, Singapore

Location

Related Publications (1)

• Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

  PMID: 37467180 DERIVED

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• YU JUN WONG, MD, MRCP FAMS

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomised, placebo-controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: March 1, 2021
• Study Start: November 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

SG (1)