Transplantation InfectionPhase 2NCT05047406
Bacillus Clausii in Liver Transplantation
A Phase 2 study testing Bacillus clausii Probiotic liquid in people with Transplantation Infection and Liver Grafting, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transplantation Infection, Liver Grafting, Hepatic Transplantation
- What is being tested?
- Bacillus clausii Probiotic liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2021to 30 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams Center for Organ Transplantation, Ain Shams Specialized Hospitals
Cairo
About this study
Official title: Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
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.
Read the 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.
- Being tested
- Bacillus clausii Probiotic liquid
- Keywords
- liver, transplantation, infection, probiotics, Bacillus clausii
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus clausii Probiotic liquidDietary supplement
Also called Enterogermina
mini bottles for oral administration containing 2 million spores of Bacillus clausii
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Bacillus clausii Probiotic liquid |
| Control (No Probiotic) | No intervention | patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
infection and mortality rates
the occurrence of post-operative bacterial infection and mortality
Measured: up to 30 days post-operatively
Secondary outcomes (10)
type of isolated bacteria
culture and sensitivity results of isolated bacteria
Measured: up to 30 days post-operatively
total hospital stay
total length of hospital stay defined as the day of surgery and day of discharge
Measured: up to 30 days post-operatively
total ICU stay
total length of ICU stay defined as the day of surgery and day of regular ward transfer
Measured: up to 30 days post-operatively
Incidence of Probiotic related adverse events
incidence of adverse events and/or side effects related to probiotics use
Measured: starting 2 weeks before surgery and up to 30 days post-operatively
Duration of antibiotic therapy
duration of antibiotic therapy after exclusion of period of antibiotic prophylaxis without signs of infection
Measured: up to 30 days post-operatively
quality of life assessment
quality of life assessment using liver disease symptom index 2.0 questionnaire
Measured: at baseline, on day 15 before surgery, and at 30 days post-transplantation
Aspartate aminotransferase level (AST)
serum aspartate aminotransferase level
Measured: at baseline before probiotic administration and at 30 days post-transplantation
Alanine aminotransferase level (ALT)
serum alanine aminotransferase level
Measured: at baseline before probiotic administration and at 30 days post-transplantation
international normalized ratio
ratio between patient's prothrombin time and that of health laboratory standard
Measured: at baseline before probiotic administration and at 30 days post-transplantation
Total bilirubin level
total serum bilirubin level
Measured: at baseline before probiotic administration and at 30 days post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Sep 2021
- Primary completion30 May 2023
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, open-label, parallel, single-center study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ezzeldin Nabet, Ain Shams University
- Investigators
- Rana Sayed, PhD, Study director, Faculty of Pharmacy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047406
- Sponsor's protocol ID
- RHDIRB2020110301REC 46
- Status last verified
- Jul 2023
- First submitted
- 9 Sep 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Administration on Infection Incidence Rate in Living Donor Liver Transplantation Recipients
- ClinicalTrials.gov ID
- NCT05047406
- Acronym / sponsor ID
- RHDIRB2020110301REC 46
- Keywords
- liver, transplantation, infection, probiotics, Bacillus clausii
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, open-label, parallel, single-center study
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Bacillus clausii Probiotic liquid2 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 |
| Control (No Probiotic) | No intervention | –patients will receive standard of care regarding immunosuppressants and antibiotic prophylaxis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus clausii Probiotic liquidAlso: Enterogerminamini bottles for oral administration containing 2 million spores of Bacillus clausii | Dietary supplement | Probiotic |
Primary outcome
infection and mortality rates
Time frame: up to 30 days post-operatively
the occurrence of post-operative bacterial infection and mortality
10 secondary outcomes
type of isolated bacteria
Time frame: up to 30 days post-operatively
total hospital stay
Time frame: up to 30 days post-operatively
total ICU stay
Time frame: up to 30 days post-operatively
Incidence of Probiotic related adverse events
Time frame: starting 2 weeks before surgery and up to 30 days post-operatively
Duration of antibiotic therapy
Time frame: up to 30 days post-operatively
quality of life assessment
Time frame: at baseline, on day 15 before surgery, and at 30 days post-transplantation
Aspartate aminotransferase level (AST)
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
Alanine aminotransferase level (ALT)
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
international normalized ratio
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
Total bilirubin level
Time frame: at baseline before probiotic administration and at 30 days post-transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Sayed, PhD study director
Faculty of Pharmacy, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacillus clausii Probiotic liquid in people with Transplantation Infection and Liver Grafting, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection and mortality rates (time frame: up to 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.