Back to resultsPrimary Prophylaxis for Spontaneous Bacterial Peritonitis (SIBOC)
Primary Purpose
Decompensated Cirrhosis, Small Bowel Bacterial Overgrowth Syndrome
Status
Terminated
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
About this trial
This is an interventional prevention trial for Decompensated Cirrhosis focused on measuring Rifaximin
Eligibility Criteria
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
Sites / Locations
- Wong Yu Jun
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control arm
Treatment arm
Arm Description
Standard of care
Outcomes
Primary Outcome Measures
Incidence of Spontaneous bacterial peritonitis
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04775329
First Posted
January 25, 2021
Last Updated
January 4, 2023
Sponsor
Changi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04775329
Brief Title
Primary Prophylaxis for Spontaneous Bacterial Peritonitis
Acronym
SIBOC
Official Title
Primary Prophylaxis for Spontaneous Bacterial Peritonitis in Decompensated Chronic Liver Disease With Small Bowel Bacterial Overgrowth: A Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment and study closure
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis, Small Bowel Bacterial Overgrowth Syndrome
Keywords
Rifaximin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomised, placebo-controlled study
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard of care
Arm Title
Treatment arm
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Rifaximin 1000mg OM
Primary Outcome Measure Information:
Title
Incidence of Spontaneous bacterial peritonitis
Description
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of all liver related events (hepatic encephalopathy, variceal bleeding, acute on chronic liver failure)
Description
To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU JUN WONG, MD, MRCP FAMS
Organizational Affiliation
Changi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wong Yu Jun
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Primary Prophylaxis for Spontaneous Bacterial Peritonitis
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