Bacillus Clausii in Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-07

Study Completion Date

2023-08-30

Brief Summary

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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.

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Detailed Description

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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

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Transplantation Infection Liver Grafting Hepatic Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, controlled, open-label, parallel, single-center study

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Probiotic

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

Group Type EXPERIMENTAL

Bacillus clausii Probiotic liquid

Intervention Type DIETARY_SUPPLEMENT

mini bottles for oral administration containing 2 million spores of Bacillus clausii

Control (No Probiotic)

patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bacillus clausii Probiotic liquid

mini bottles for oral administration containing 2 million spores of Bacillus clausii

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Enterogermina

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No