Bacillus Clausii in Liver Transplantation

Ain Shams University

Status and phase: Active, not recruiting; Phase 2

Conditions: Liver Grafting; Hepatic Transplantation; Transplantation Infection

Treatments: Dietary Supplement: Bacillus clausii Probiotic liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT05047406

RHDIRB2020110301REC 46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Probiotic

Experimental group

Description:

2 oral mini-bottles daily of Bacillus clausii probiotic liquid containing 2 billion spores/bottle for 2 weeks before living donor liver transplantation surgery In addition, patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis

Treatment:

Dietary Supplement: Bacillus clausii Probiotic liquid

Control (No Probiotic)

No Intervention group

Description:

patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis