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The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.
Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.
However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin Treatment Group | Experimental | Rifaximin 400mg bid for 2 months, |
|
| Control Group | No Intervention | Receive routine endoscopic treatment without having rifaximin for 2 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Patients receive Rifaximin 400mg bid for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all clinical adverse events | The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of portal vein thrombosis | complete or partial recanalization of thrombosis | 2 months |
| Changes of intestinal flora | Metagenomics sequencing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyao CHEN, M.D. | Zhongshan Hospital, Fudan University, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39443081 | Derived | Huang XQ, Ai YJ, Li F, Ye ST, Wang JH, Zhang R, Zhang W, Zhu YL, Chen SY. Impact of rifaximin on cirrhosis complications and gastric microbiota in patients with gastroesophageal variceal bleeding: A pilot randomized controlled trial. J Dig Dis. 2024 Aug;25(8):504-516. doi: 10.1111/1751-2980.13314. | |
| 37467180 | Derived |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004932 | Esophageal and Gastric Varices |
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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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| 2 months |
| The changes of serum level of cytokines | Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc | 8 weeks |
| 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. |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D006470 | Hemorrhage |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |