FMT Guidelines

Welcome to the FMT-Life Fecal Microbiota Transplantation (FMT) Guidelines. These guidelines are designed to assist healthcare professionals in the effective and safe use of FMT to treat patients with recurrent C. difficile infections and other related conditions.

1. Patient Eligibility

Recurrent C. difficile Infections:

• Primary Indication: FMT is indicated for patients with recurrent C. difficile infections that have not responded to standard antibiotic treatments.

• Eligibility Criteria:

  • Documented history of recurrent C. difficile infection (usually defined as three or more episodes).

  • Failure to achieve sustained remission with standard antibiotic therapy.

  • No contraindications to FMT, such as severe immunosuppression or significant comorbid conditions that would pose an additional risk.

Other Indications:

• Investigational Use: FMT may be considered for other conditions based on ongoing research. Always consult the latest research and clinical trials for emerging indications.

2. Preparation and Administration

Preparation:

• Source Material: FMT preparations are derived from healthy, screened donors. Each batch is carefully processed to ensure safety and efficacy.

• Storage: Preparations are stored under controlled conditions until delivery. Ensure that storage and handling protocols are followed to maintain viability.

Administration Techniques:

• Colonoscopy: The most common method for administering FMT. The preparation is delivered directly into the colon via colonoscopy.

• Enema: An alternative method where the FMT preparation is administered via enema.

• Nasogastric Tube: In cases where colonoscopy is not feasible, FMT can be delivered via a nasogastric tube.

• Oral Capsules: Available as a less invasive option, oral capsules containing lyophilized FMT material are administered.

Procedure:

• Preparation: Ensure patient consent is obtained and pre-procedure instructions are provided.

• Administration: Follow the specific protocol for the chosen administration method. Ensure all equipment and materials are sterile.

• Post-Procedure: Monitor the patient for any immediate reactions. Provide post-procedure care instructions, including potential side effects and follow-up.

3. Safety and Monitoring

Safety Measures:

• Screening: Use FMT preparations only from donors who have been thoroughly screened for infectious diseases and other health conditions.

• Adverse Effects: Monitor for potential side effects such as gastrointestinal discomfort, fever, or allergic reactions. Report any adverse effects to FMT-Life.

Monitoring:

• Follow-Up: Schedule follow-up appointments to assess patient response and recovery. Evaluate the efficacy of the treatment and monitor for any recurrence of C. difficile infection.

• Data Collection: Collect and document patient outcomes to contribute to ongoing research and improve treatment protocols.

4. Documentation and Reporting

Record-Keeping:

• Patient Records: Maintain detailed records of the FMT procedure, including patient consent, preparation details, administration method, and post-procedure outcomes.

• Regulatory Compliance: Ensure compliance with all relevant regulations and guidelines. Report any incidents or deviations from the standard protocol to regulatory bodies if required.

Reporting:

• Clinical Network: Report outcomes and any issues to the FMT-Life Clinical Network to contribute to the collective knowledge and improvement of FMT practices.

• Research Contribution: Engage in research studies and trials to help advance the science of FMT and expand its applications.

5. Resources and Support

Educational Resources:

• Training Modules: Access our training materials and modules to stay updated on best practices and new developments in FMT.

• Support Team: Contact our support team for any questions or assistance with FMT procedures at info@fmt.life or 617-575-2201.

Clinical Network:

• Join Us: Become a member of the FMT-Life Clinical Network to gain access to the latest FMT treatments, guidelines, and support resources.

Contact Information

For additional information or support, please contact us at:

• Email: info@fmt.life

• Phone: 617-575-2201

• Fax: 617-575-2201

Thank you for your commitment to advancing patient care with Fecal Microbiota Transplantation. We are here to support you in providing the best possible outcomes for your patients.