Bacillus Clausii in Liver Transplantation

Transplantation Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05047406
• Other study ID #: RHDIRB2020110301REC 46
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 7, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Transplantation
• Infections
• Transplantation Infection

Intervention

Dietary Supplement:
• Bacillus clausii Probiotic liquid
mini bottles for oral administration containing 2 million spores of Bacillus clausii

Locations

Country	Name	City	State
Egypt	Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection and mortality rates	the occurrence of post-operative bacterial infection and mortality	up to 30 days post-operatively
Secondary	type of isolated bacteria	culture and sensitivity results of isolated bacteria	up to 30 days post-operatively
Secondary	total hospital stay	total length of hospital stay defined as the day of surgery and day of discharge	up to 30 days post-operatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Aspartate aminotransferase level (AST)	serum aspartate aminotransferase level	at baseline before probiotic administration and at 30 days post-transplantation
Secondary	Alanine aminotransferase level (ALT)	serum alanine aminotransferase level	at baseline before probiotic administration and at 30 days post-transplantation
Secondary	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
Secondary	Total bilirubin level	total serum bilirubin level	at baseline before probiotic administration and at 30 days post-transplantation