Hepatic Transplantation, Liver Grafting, Transplantation Infection
Conditions
Keywords
liver, transplantation, infection, probiotics, Bacillus clausii
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBacillus clausii Probiotic liquid
mini bottles for oral administration containing 2 million spores of Bacillus clausii
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective, randomized, controlled, open-label, parallel, single-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 - 65 years. * Patients suffering from end stage liver disease (ESLD) with any etiology listed on waiting list and accepting to volunteer in the study with the informed consent. * Patients not suffering from any active infection at the start of the study.
Exclusion criteria
* Patients with poorly controlled autoimmune disease on immunosuppression before transplantation. * Patients who undergo combined kidney-liver transplantation. * Patients with severe renal insufficiency (creatinine clearance \<50 ml/min). * Patients with intestinal obstruction (ileus). * Patients with cerebral disorders with danger of aspiration. * Patients with roux en Y-anastomosis. * Patients with cystic fibrosis. * Retransplantation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| infection and mortality rates | up to 30 days post-operatively | the occurrence of post-operative bacterial infection and mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total hospital stay | up to 30 days post-operatively | total length of hospital stay defined as the day of surgery and day of discharge |
| total ICU stay | up to 30 days post-operatively | total length of ICU stay defined as the day of surgery and day of regular ward transfer |
| Incidence of Probiotic related adverse events | starting 2 weeks before surgery and up to 30 days post-operatively | incidence of adverse events and/or side effects related to probiotics use |
| Duration of antibiotic therapy | up to 30 days post-operatively | duration of antibiotic therapy after exclusion of period of antibiotic prophylaxis without signs of infection |
| type of isolated bacteria | up to 30 days post-operatively | culture and sensitivity results of isolated bacteria |
| Aspartate aminotransferase level (AST) | at baseline before probiotic administration and at 30 days post-transplantation | serum aspartate aminotransferase level |
| Alanine aminotransferase level (ALT) | at baseline before probiotic administration and at 30 days post-transplantation | serum alanine aminotransferase level |
| international normalized ratio | at baseline before probiotic administration and at 30 days post-transplantation | ratio between patient's prothrombin time and that of health laboratory standard |
| Total bilirubin level | at baseline before probiotic administration and at 30 days post-transplantation | total serum bilirubin level |
| quality of life assessment | at baseline, on day 15 before surgery, and at 30 days post-transplantation | quality of life assessment using liver disease symptom index 2.0 questionnaire |
Countries
Egypt
Outcome results
None listed