Clinical trial NCT05047406: Bacillus Clausii in Liver Transplantation
Official title: Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Transplantation Infection
Liver Grafting
Hepatic Transplantation
Keywords: liver
transplantation
infection
probiotics
Bacillus clausii
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, open-label, parallel, single-center study
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: infection and mortality rates
timeFrame: up to 30 days post-operatively
Secondary outcomes:
measure: type of isolated bacteria
timeFrame: up to 30 days post-operatively
measure: total hospital stay
timeFrame: up to 30 days post-operatively
measure: total ICU stay
timeFrame: up to 30 days post-operatively
measure: Incidence of Probiotic related adverse events
timeFrame: starting 2 weeks before surgery and up to 30 days post-operatively
measure: Duration of antibiotic therapy
timeFrame: up to 30 days post-operatively
measure: quality of life assessment
timeFrame: at baseline, on day 15 before surgery, and at 30 days post-transplantation
measure: Aspartate aminotransferase level (AST)
timeFrame: at baseline before probiotic administration and at 30 days post-transplantation
measure: Alanine aminotransferase level (ALT)
timeFrame: at baseline before probiotic administration and at 30 days post-transplantation
measure: international normalized ratio
timeFrame: at baseline before probiotic administration and at 30 days post-transplantation
measure: Total bilirubin level
timeFrame: at baseline before probiotic administration and at 30 days post-transplantation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams University
name: Rana Sayed, PhD
role: STUDY_DIRECTOR
References: