SIBOC: Primary Prophylaxis for Spontaneous Bacterial Peritonitis

Sponsor

Changi General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775329

Collaborator

(none)

Enrollment

Location

Arms

31.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Decompensated Cirrhosis Small Bowel Bacterial Overgrowth Syndrome	Drug: Rifaximin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Randomised, placebo-controlled study

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control arm Standard of care
Active Comparator: Treatment arm	Drug: Rifaximin Rifaximin 1000mg OM

Arm

Intervention/Treatment

No Intervention: Control arm

Standard of care

Active Comparator: Treatment arm

Drug: Rifaximin

Rifaximin 1000mg OM

Outcome Measures

Primary Outcome Measures

Incidence of Spontaneous bacterial peritonitis [12 months]
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) [12 months]
To study and understand the immunophysiological and gut microbiota changes associated with bowel decontamination among cirrhosis patients with SIBO using serum biomarkers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wong Yu Jun	Singapore		Singapore	529889

Sponsors and Collaborators

Changi General Hospital

Investigators

Principal Investigator: YU JUN WONG, MD, MRCP FAMS, Changi General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changi General Hospital

ClinicalTrials.gov Identifier:

NCT04775329

Other Study ID Numbers:

SIBOC

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Changi General Hospital

Rifaximin

Additional relevant MeSH terms:

Peritonitis

Blind Loop Syndrome

Rifaximin

Study Results

No Results Posted as of Mar 1, 2021