Bacillus Clausii in Liver Transplantation

Phase 2

Active, not recruiting

• Conditions: Liver Grafting; Transplantation Infection; Hepatic Transplantation
• Interventions: Dietary Supplement: Bacillus clausii Probiotic liquid

• Registration Number: NCT05047406
• Lead Sponsor: Ain Shams University

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 Timeline

• Study Start: 2021-09-07
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-11
• Study First Posted: 2021-09-17
• Primary Completion: 2023-05-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Bacillus clausii Probiotic liquid	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

Primary Outcome Measures

Name	Time	Method
infection and mortality rates	up to 30 days post-operatively	the occurrence of post-operative bacterial infection and mortality

Secondary Outcome Measures

Name	Time	Method
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
type of isolated bacteria	up to 30 days post-operatively	culture and sensitivity results of isolated bacteria
total hospital stay	up to 30 days post-operatively	total length of hospital stay defined as the day of surgery and day of discharge
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
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
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
Aspartate aminotransferase level (AST)	at baseline before probiotic administration and at 30 days post-transplantation	serum aspartate 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
Alanine aminotransferase level (ALT)	at baseline before probiotic administration and at 30 days post-transplantation	serum alanine aminotransferase level

Trial Locations

Locations (1)

Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals; 🇪🇬 Cairo, Egypt