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Slow recruitment and study closure
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Standard of care | |
| Treatment arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Rifaximin 1000mg OM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Spontaneous bacterial peritonitis | To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YU JUN WONG, MD, MRCP FAMS | Changi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wong Yu Jun | Singapore | 529889 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37467180 | Derived | 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. |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Randomised, placebo-controlled study
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |