Transplantation Infection Clinical Trial
Official title:
Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
Verified date | July 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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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