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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05047406
Other study ID # RHDIRB2020110301REC 46
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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