Clinical Data

At FMT-Life, we prioritize the collection, analysis, and application of clinical data to enhance the efficacy and safety of Fecal Microbiota Transplantation (FMT). This section provides insights into the clinical data supporting FMT, including efficacy, safety profiles, and ongoing research.

1. Overview of Clinical Data

FMT Efficacy:

• Primary Indication: The primary indication for FMT is the treatment of recurrent Clostridium difficile infections (CDI). Clinical studies have shown that FMT is highly effective in achieving remission in patients with recurrent CDI, often after traditional antibiotic therapies have failed.

• Success Rates: Studies report success rates of up to 80-90% for achieving clinical resolution of recurrent CDI following FMT. These rates are based on multiple clinical trials and real-world data.

Long-Term Outcomes:

• Sustained Remission: Data indicate that FMT not only resolves acute symptoms but also provides long-term protection against CDI recurrence. Long-term follow-up studies suggest that patients maintain remission for extended periods after the procedure.

• Health Improvements: Beyond CDI, FMT may contribute to improvements in overall gut health and the resolution of associated symptoms such as diarrhea and abdominal pain.

2. Safety Profile

Adverse Events:

• Common Side Effects: The most common side effects reported are mild gastrointestinal symptoms such as bloating, gas, and diarrhea. These are typically transient and resolve within a few days.

• Serious Adverse Events: Serious adverse events are rare but may include infections or reactions to the procedure. Comprehensive screening of donor material and adherence to protocol minimizes these risks.

Monitoring and Reporting:

• Pre-Procedure Screening: Thorough screening of donor stool and patient health history reduces the risk of adverse events.

• Post-Procedure Monitoring: Continuous monitoring and follow-up care are essential for detecting and managing any potential complications.

3. Research and Evidence

Clinical Trials:

• Ongoing Trials: FMT-Life actively participates in and supports ongoing clinical trials to explore new indications for FMT and refine existing protocols. These trials contribute to the growing body of evidence supporting the use of FMT in various clinical scenarios.

• Published Studies: Numerous studies have been published demonstrating the efficacy and safety of FMT. These studies provide valuable insights into the optimal use of FMT and inform clinical practice.

Data Sharing:

• Collaborative Research: We collaborate with research institutions and clinical networks to advance the understanding of FMT. Data from these collaborations contribute to the development of new treatment guidelines and protocols.

4. Data Access and Utilization

Clinical Data Repository:

• Access to Data: FMT-Life maintains a comprehensive repository of clinical data related to FMT treatments. This data is used to analyze trends, evaluate outcomes, and improve treatment strategies.

• Utilization for Improvement: The data collected helps in refining protocols, enhancing patient selection criteria, and optimizing treatment approaches.

Data Contribution:

• Clinical Partners: Clinical partners are encouraged to contribute their data and experiences to the FMT-Life database. This collective data helps in advancing research and improving the overall effectiveness of FMT treatments.

5. Reporting and Compliance

Regulatory Reporting:

• Compliance: We ensure compliance with regulatory requirements for data reporting and management. This includes adhering to guidelines for patient privacy and data protection.

• Incident Reporting: Any adverse events or deviations from standard protocols are reported to regulatory bodies as required.

Transparency and Publication:

• Publications: We publish findings from our clinical data in peer-reviewed journals and present them at conferences to share knowledge with the broader medical community.

• Data Transparency: We are committed to transparency in our research and clinical practices, providing access to data and findings for review and analysis.

Contact Information

For more information on clinical data, research opportunities, or to contribute to our data repository, please contact us at:

• Email: info@fmt.life

• Phone: 617-575-2201

• Fax: 617-575-2201

Thank you for your dedication to advancing patient care through Fecal Microbiota Transplantation. Your contributions and collaboration are essential to the ongoing success and improvement of FMT treatments.