Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04775329
Status:
TERMINATED
Last Update Posted:
2023-01-06
First Post:
2021-01-25
Brief Title:
Primary Prophylaxis for Spontaneous Bacterial Peritonitis
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth A Randomised Trial
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment and study closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIBOC
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None