A Phase 2/3 interventional study of Rifaximin in Decompensated Cirrhosis and Small Bowel Bacterial Overgrowth Syndrome, sponsored by Changi General Hospital. Terminated at 1 site in Singapore. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-06.
Sponsored by Changi General Hospital · Phase 2/3, Interventional, and Prevention
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.
11 studies on the registry are indexed under Blind Loop Syndrome; 4 are open to participants now.
This study's enrollment of 2 is below the median of 48 across 10 interventional studies indexed under Blind Loop Syndrome.
Browse Blind Loop Syndrome studies →Changi General Hospital is the lead sponsor of 101 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care
Drug: Rifaximin
Rifaximin 1000mg OM
Incidence of Spontaneous bacterial peritonitis
To determine the rate of cirrhosis-related complications, with and without Rifaximin among decompensated cirrhosis with SIBO.
Time frame: 12 months
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.
Time frame: 12 months
Plan to share: Undecided
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This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rifaximin