NCT05047406

Bacillus Clausii in Liver Transplantation

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transplantation Infection
• Liver Grafting
• Hepatic Transplantation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bacillus clausii Probiotic liquid	mini bottles for oral administration containing 2 million spores of Bacillus clausii

Timeline

• Start date: 2021-09-07
• Primary completion: 2023-05-30
• Completion: 2023-08-30
• First posted: 2021-09-17
• Last updated: 2023-07-24

Locations

1 site across 1 country: Egypt