Evaluation of Fecal Microbiota Transplantation on Cytochrome P450 Enzyme Activities in Patients with Irritable Bowel Syndrome and Clostridioides difficile Infection

The primary objective of the KF2022#1 trial is to evaluate the effect of **fecal microbiota transplantation** on the activities of **CYP enzymes** in patients with **irritable bowel syndrome** and **Clostridioides difficile** infection. Understanding the impact of this intervention on CYP enzyme activities is clinically relevant as these enzymes play a crucial role in drug metabolism, which can affect the efficacy and safety of pharmacological treatments in these conditions.

The clinical trial involves participants diagnosed with **irritable bowel syndrome** and **Clostridioides difficile** infection. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, which typically represent adults and older adults. The trial population selection criteria include a focus on a vulnerable population, although specific inclusion or exclusion criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. Lifestyle considerations such as diet, physical activity, or habits have not been specified in the available data.

The clinical trial is designed to evaluate the effect of **fecal microbiota transplantation** on CYP enzyme activities in patients with **irritable bowel syndrome** and **Clostridioides difficile** infection. This study is a Phase 3, randomized, double-blind, controlled trial, with an estimated recruitment start date of January 5, 2023, and an anticipated end date of December 31, 2025. The trial will involve multiple study visits, beginning with an inclusion visit where participants will be screened for eligibility based on specific criteria. Following successful screening, participants will be randomly assigned to either the treatment or control group, ensuring the double-blind nature of the study is maintained.

Participants will be required to attend several follow-up visits throughout the trial duration to monitor their response to the treatment and assess any potential side effects. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the intervention. The expected length of participant involvement will vary depending on individual response and adherence to the study protocol, but it is anticipated to last until the trial's completion in 2025. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of adverse events that compromise participant safety.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on January 5, 2023, with an estimated completion date of December 31, 2025. Efficacy will be evaluated using specific parameters or endpoints, although these are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to rigorous standards typical of Phase 3 studies, ensuring that the efficacy assessments are conducted with scientific precision and reliability. The trial's design and execution will follow established protocols to ensure the validity and reliability of the efficacy data collected throughout the study period.