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Bacillus Clausii in Liver Transplantation

Primary Purpose

Transplantation Infection, Liver Grafting, Hepatic Transplantation

Status
Active
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bacillus clausii Probiotic liquid
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transplantation Infection focused on measuring liver, transplantation, infection, probiotics, Bacillus clausii

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotic

Control (No Probiotic)

Arm Description

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

patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis

Outcomes

Primary Outcome Measures

infection and mortality rates
the occurrence of post-operative bacterial infection and mortality

Secondary Outcome Measures

type of isolated bacteria
culture and sensitivity results of isolated bacteria
total hospital stay
total length of hospital stay defined as the day of surgery and day of discharge
total ICU stay
total length of ICU stay defined as the day of surgery and day of regular ward transfer
Incidence of Probiotic related adverse events
incidence of adverse events and/or side effects related to probiotics use
Duration of antibiotic therapy
duration of antibiotic therapy after exclusion of period of antibiotic prophylaxis without signs of infection
quality of life assessment
quality of life assessment using liver disease symptom index 2.0 questionnaire
Aspartate aminotransferase level (AST)
serum aspartate aminotransferase level
Alanine aminotransferase level (ALT)
serum alanine aminotransferase level
international normalized ratio
ratio between patient's prothrombin time and that of health laboratory standard
Total bilirubin level
total serum bilirubin level

Full Information

First Posted
September 9, 2021
Last Updated
July 20, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05047406
Brief Title
Bacillus Clausii in Liver Transplantation
Official Title
Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplantation Infection, Liver Grafting, Hepatic Transplantation
Keywords
liver, transplantation, infection, probiotics, Bacillus clausii

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled, open-label, parallel, single-center study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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
Arm Title
Control (No Probiotic)
Arm Type
No Intervention
Arm Description
patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis
Intervention Type
Dietary Supplement
Intervention Name(s)
Bacillus clausii Probiotic liquid
Other Intervention Name(s)
Enterogermina
Intervention Description
mini bottles for oral administration containing 2 million spores of Bacillus clausii
Primary Outcome Measure Information:
Title
infection and mortality rates
Description
the occurrence of post-operative bacterial infection and mortality
Time Frame
up to 30 days post-operatively
Secondary Outcome Measure Information:
Title
type of isolated bacteria
Description
culture and sensitivity results of isolated bacteria
Time Frame
up to 30 days post-operatively
Title
total hospital stay
Description
total length of hospital stay defined as the day of surgery and day of discharge
Time Frame
up to 30 days post-operatively
Title
total ICU stay
Description
total length of ICU stay defined as the day of surgery and day of regular ward transfer
Time Frame
up to 30 days post-operatively
Title
Incidence of Probiotic related adverse events
Description
incidence of adverse events and/or side effects related to probiotics use
Time Frame
starting 2 weeks before surgery and up to 30 days post-operatively
Title
Duration of antibiotic therapy
Description
duration of antibiotic therapy after exclusion of period of antibiotic prophylaxis without signs of infection
Time Frame
up to 30 days post-operatively
Title
quality of life assessment
Description
quality of life assessment using liver disease symptom index 2.0 questionnaire
Time Frame
at baseline, on day 15 before surgery, and at 30 days post-transplantation
Title
Aspartate aminotransferase level (AST)
Description
serum aspartate aminotransferase level
Time Frame
at baseline before probiotic administration and at 30 days post-transplantation
Title
Alanine aminotransferase level (ALT)
Description
serum alanine aminotransferase level
Time Frame
at baseline before probiotic administration and at 30 days post-transplantation
Title
international normalized ratio
Description
ratio between patient's prothrombin time and that of health laboratory standard
Time Frame
at baseline before probiotic administration and at 30 days post-transplantation
Title
Total bilirubin level
Description
total serum bilirubin level
Time Frame
at baseline before probiotic administration and at 30 days post-transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rana Sayed, PhD
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Bacillus Clausii in Liver Transplantation

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