Evaluation of Transfer Factor TFI on Recurrent Respiratory, Urinary Tract, and Herpetic Infections in a Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this clinical trial is to evaluate the **efficacy** of Transfer Factor TFI treatment in reducing the number of new infections in subjects with recurrent **respiratory infections**, recurrent **urinary tract infections**, or recurrent **herpetic infections** over a period of 6 months from randomization. This is clinically relevant as it aims to provide a potential therapeutic option for individuals suffering from these recurrent infections, which can significantly impact quality of life and lead to increased healthcare utilization.

The clinical trial involves a study population comprising both **male** and **female** participants, with an age range categorized as **3**, which typically includes adults. The trial population was selected to include individuals with a history of **recurrent respiratory infections**, **recurrent urinary tract infections**, and **recurrent herpetic infections**. The sponsor has not provided information regarding the total number of participants. The trial includes a vulnerable population, indicating that special considerations may be necessary for their participation. Lifestyle factors such as diet, physical activity, or habits have not been specified. The sponsor has not disclosed specific inclusion or exclusion criteria for this study.

The clinical trial is designed as a **randomized, double-blind, placebo-controlled** study to evaluate the efficacy of Transfer Factor TFI treatment. The primary focus is on assessing the number of new infections in subjects with **recurrent respiratory infections**, **recurrent urinary tract infections**, or **recurrent herpetic infections** over a period of six months from randomization. The trial is set to commence recruitment on December 2, 2024, and is expected to conclude by December 30, 2025.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following randomization, participants will attend regular follow-up visits to monitor health status, adherence to the study protocol, and any adverse events. These visits are crucial for collecting data on the incidence of new infections and ensuring participant safety. The end-of-study visit will occur at the conclusion of the six-month period, where final assessments will be conducted to evaluate the treatment's efficacy.

The expected length of participant involvement is approximately six months, aligning with the duration of the treatment and observation period. Conditions that may lead to early termination from the study include non-compliance with the study protocol, withdrawal of consent, or the occurrence of significant adverse events that compromise participant safety. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the integrity of the data and the well-being of the participants.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized under phase 5, indicating a focus on post-marketing surveillance to gather additional information on the drug's effectiveness and safety. The estimated recruitment start date is December 2, 2024, with an anticipated end date of December 30, 2025. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, the trial will likely involve systematic data collection and analysis to determine the treatment's impact on the targeted medical condition. The trial's design will adhere to rigorous scientific standards to ensure the reliability and validity of the efficacy assessments.