Bacillus Clausii in Liver Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients

Conditions
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Transplantation Infection, Liver Grafting, Hepatic Transplantation

Intervention / Treatment
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* Dietary Supplement: Bacillus clausii Probiotic liquid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, open-label, parallel, single-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>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 | Dietary Supplement: Bacillus clausii Probiotic liquid<br>* mini bottles for oral administration containing 2 million spores of Bacillus clausii<br>* Other names: Enterogermina;|
| No Intervention: Control (No Probiotic)<br>patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection and mortality rates | the occurrence of post-operative bacterial infection and mortality | up to 30 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver, transplantation, infection, probiotics, Bacillus clausii