Bacillus Clausii in Liver Transplantation

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05047406

Collaborator

(none)

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplantation Infection Liver Grafting Hepatic Transplantation	Dietary Supplement: Bacillus clausii Probiotic liquid	Phase 2

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

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, controlled, open-label, parallel, single-center studyProspective, randomized, controlled, open-label, parallel, single-center study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 7, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

infection and mortality rates [up to 30 days post-operatively]
the occurrence of post-operative bacterial infection and mortality

Secondary Outcome Measures

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
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
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
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
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
Alanine aminotransferase level (ALT) [at baseline before probiotic administration and at 30 days post-transplantation]
serum alanine 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.