Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- infection and mortality rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Probiotic
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
Intervention: Bacillus clausii Probiotic liquid (Dietary Supplement)
Control (No Probiotic)
patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis
Outcomes
Primary Outcomes
infection and mortality rates
Time Frame: up to 30 days post-operatively
the occurrence of post-operative bacterial infection and mortality
Secondary Outcomes
- Incidence of Probiotic related adverse events(starting 2 weeks before surgery and up to 30 days post-operatively)
- type of isolated bacteria(up to 30 days post-operatively)
- total hospital stay(up to 30 days post-operatively)
- Duration of antibiotic therapy(up to 30 days post-operatively)
- total ICU stay(up to 30 days post-operatively)
- quality of life assessment(at baseline, on day 15 before surgery, and at 30 days post-transplantation)
- Aspartate aminotransferase level (AST)(at baseline before probiotic administration and at 30 days post-transplantation)
- international normalized ratio(at baseline before probiotic administration and at 30 days post-transplantation)
- Total bilirubin level(at baseline before probiotic administration and at 30 days post-transplantation)
- Alanine aminotransferase level (ALT)(at baseline before probiotic administration and at 30 days post-transplantation)
Investigators
Dina Ezzeldin Nabet
Principal investigator
Ain Shams University