Investigating the prophylactic effect of probiotics on diarrhea in liver transplant recipient

Primary Objectives of the Study: To examine the difference in the incidence of diarrhea following liver transplantation surgery between the probiotic treatment group and the placebo group.

This single-center, randomized, double-blind, placebo-controlled parallel-group clinical trial will involve 120 adult patients (aged 18-70) undergoing their first liver transplant at Imam Khomeini Hospital over a two-year period. Patients will be randomly assigned in a 1:1 ratio to either the probiotic group, receiving Lactocare (2 capsules daily for two weeks post-transplant), or the placebo group, with identical capsules containing an inactive filler. Randomization will be done using computer-generated blocks of 4 and 6, and all study personnel will remain blinded until the study's conclusion. The study aims to assess the incidence and causes of post-transplant diarrhea and compare infectious and non-infectious complications, graft survival, and mortality rates between the two groups.

all study personnel will remain blinded until the study's conclusion

Inclusion Criteria: age 18-70 years. first liver transplantation. Ability to swallow oral capsules. Exclusion Criteria: Pregnant, breastfeeding Active and uncontrolled immunodeficiency disorders not related to liver disease. History of allergy or intolerance to probiotics. Use of probiotics within two weeks prior to the start of the study. Presence of diarrhea at the time of study initiation.

Patients in the treatment group will use Lactocare probiotics from the Zist Takhmir Company, taking two capsules daily. Identical placebo capsules containing an inactive filler (starch) will be administered in the same manner as the active drug.

the incidence of diarrhea within the first 30 days after liver transplantation.

Randomization description: Computerized randomization 1:1 with randomized blocks of 4 and 6 will be created by an independent statistical specialist. The treatment groups will be coded and sealed. All study staff, laboratory personnel, and data analysts will remain blinded until the end of the study. Double-blinding will be enhanced by preparing and packaging the protocols and solutions identically. The process of randomizing and distributing the solutions will be handled directly by an investigator who is not involved in the study. Emergency procedures that require knowledge of the intervention allocation are in place to ensure participant safety if necessary.

Blinding Explanation: In our study, blinding has been meticulously implemented to ensure the integrity and reliability of the results. The following individuals and methods are involved in maintaining the blinding: Participants: All participants are blinded to their group allocation. They are informed that they are part of a study, but they do not know whether they are receiving the probiotic or the placebo. Principal Investigator: The principal investigator is also blinded to the group allocations. This ensures that there is no bias in the interpretation of results or the management of participants. Healthcare Personnel: All healthcare personnel, including doctors, nurses, and physiotherapists responsible for patient care, are blinded to the group allocations. This is to ensure that the care provided is consistent and unbiased. Data Collection Staff: Individuals responsible for data collection are blinded to the group allocations to prevent any bias in data recording and handling. Outcome Assessors: The assessors who evaluate the study outcomes are blinded to group allocations to ensure unbiased assessment of results. Data Safety and Monitoring Board (DSMB): Although less critical, the DSMB is aware of the group allocations to monitor safety and overall study conduct, ensuring no conflicts arise during the trial. Manuscript Preparers: Individuals involved in preparing the draft of the manuscript are blinded to the group allocations to ensure an unbiased interpretation and reporting of results.