Bacillus Clausii in Liver Transplantation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Transplantation Infection; Liver Grafting; Hepatic Transplantation
• Intervention / Treatment: Dietary supplement: Bacillus clausii Probiotic liquid

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Rana Sayed, PhD, Faculty of Pharmacy, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): August 30, 2023

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 11, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; infection; transplantation; liver; Bacillus clausii
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: RHDIRB2020110301REC 46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No