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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
mini bottles for oral administration containing 2 million spores of Bacillus clausii
Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals
Cairo, Egypt
infection and mortality rates
the occurrence of post-operative bacterial infection and mortality
Time frame: up to 30 days post-operatively
type of isolated bacteria
culture and sensitivity results of isolated bacteria
Time frame: up to 30 days post-operatively
total hospital stay
total length of hospital stay defined as the day of surgery and day of discharge
Time frame: 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
Time frame: up to 30 days post-operatively
Incidence of Probiotic related adverse events
incidence of adverse events and/or side effects related to probiotics use
Time frame: 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
Time frame: up to 30 days post-operatively
quality of life assessment
quality of life assessment using liver disease symptom index 2.0 questionnaire
Time frame: at baseline, on day 15 before surgery, and at 30 days post-transplantation
Aspartate aminotransferase level (AST)
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serum aspartate aminotransferase level
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
Alanine aminotransferase level (ALT)
serum alanine aminotransferase level
Time frame: 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
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
Total bilirubin level
total serum bilirubin level
Time frame: at baseline before probiotic administration and at 30 days post-transplantation