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A prospective, randomized, controlled study of the safety and efficacy of using Bacillus clausii probiotic oral preparation to decrease the incidence of infection during the first 30 days after living donor liver transplantation surgery.
Patients planned for living donor liver transplantation would be randomized to either intervention or control group 2 weeks before surgery. Intervention group shall receive Bacillus clausii probiotics for 2 weeks. patients in both groups would be followed-up for adverse events and signs and symptoms of infection up to 30 days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 2 oral mini-bottles daily of Bacillus clausii probiotic liquid containing 2 billion spores/bottle for 2 weeks before living donor liver transplantation surgery In addition, patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis |
|
| Control (No Probiotic) | No Intervention | patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus clausii Probiotic liquid | Dietary Supplement | mini bottles for oral administration containing 2 million spores of Bacillus clausii |
|
| Measure | Description | Time Frame |
|---|---|---|
| infection and mortality rates | the occurrence of post-operative bacterial infection and mortality | up to 30 days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| type of isolated bacteria | culture and sensitivity results of isolated bacteria | up to 30 days post-operatively |
| total hospital stay | total length of hospital stay defined as the day of surgery and day of discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rana Sayed, PhD | Faculty of Pharmacy, Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals | Cairo | Egypt |
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| ID | Term |
|---|---|
| D007239 | Infections |
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Prospective, randomized, controlled, open-label, parallel, single-center study
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| up to 30 days post-operatively |
| total ICU stay | total length of ICU stay defined as the day of surgery and day of regular ward transfer | up to 30 days post-operatively |
| Incidence of Probiotic related adverse events | incidence of adverse events and/or side effects related to probiotics use | starting 2 weeks before surgery and up to 30 days post-operatively |
| Duration of antibiotic therapy | duration of antibiotic therapy after exclusion of period of antibiotic prophylaxis without signs of infection | up to 30 days post-operatively |
| quality of life assessment | quality of life assessment using liver disease symptom index 2.0 questionnaire | at baseline, on day 15 before surgery, and at 30 days post-transplantation |
| Aspartate aminotransferase level (AST) | serum aspartate aminotransferase level | at baseline before probiotic administration and at 30 days post-transplantation |
| Alanine aminotransferase level (ALT) | serum alanine aminotransferase level | at baseline before probiotic administration and at 30 days post-transplantation |
| international normalized ratio | ratio between patient's prothrombin time and that of health laboratory standard | at baseline before probiotic administration and at 30 days post-transplantation |
| Total bilirubin level | total serum bilirubin level | at baseline before probiotic administration and at 30 days post-transplantation |