Bacillus Clausii in Liver Transplantation

NCT05047406 | Unknown Phase 2

• 1 other identifier: RHDIRB2020110301REC 46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplantation Infection; Liver Grafting; Hepatic Transplantation

Keywords

liver; transplantation; infection; probiotics; Bacillus clausii

Outcome Measures

Primary Outcomes (1)

• infection and mortality rates

  the occurrence of post-operative bacterial infection and mortality

  up to 30 days post-operatively

Secondary Outcomes (10)

• type of isolated bacteria

  up to 30 days post-operatively

• total hospital stay

  up to 30 days post-operatively

• total ICU stay

  up to 30 days post-operatively

• Incidence of Probiotic related adverse events

  starting 2 weeks before surgery and up to 30 days post-operatively

• Duration of antibiotic therapy

  up to 30 days post-operatively

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Bacillus clausii Probiotic liquid

Control (No Probiotic)

NO INTERVENTION

patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis

Interventions

Bacillus clausii Probiotic liquid DIETARY_SUPPLEMENT

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

Also known as: Enterogermina

Probiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Infections

Study Officials

• Rana Sayed, PhD

  Faculty of Pharmacy, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, randomized, controlled, open-label, parallel, single-center study

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: September 7, 2021
• Primary Completion: May 30, 2023
• Study Completion: August 30, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)