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UNKNOWNPHASE2

Bacillus Clausii in Liver Transplantation

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

NCT05047406•Ain Shams University

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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.

Locations (1)

Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals

Cairo, Egypt

Key Dates

Start Date

September 7, 2021

Primary Completion Date

May 30, 2023

Completion Date

August 30, 2023

Last Updated

July 24, 2023

Enrollment

ACTUAL participants

Conditions

Transplantation InfectionLiver GraftingHepatic Transplantation

Interventions

Bacillus clausii Probiotic liquid

DIETARY_SUPPLEMENT

High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)

NCT07192458

Immunization; Infection|Transplantation Infection|InfluenzaInfluenza

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RECRUITING

Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

NCT01515605

Transplantation InfectionKidney Diseases

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Bacillus Clausii in Liver Transplantation

Inclusion Criteria

Exclusion Criteria

High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)

Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)

Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)

Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients