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Updated: Apr 15, 2026
Fecal Microbiota Transplantation via Colonoscopy for Recurrent C. difficile Infection
Published on: December 8, 2014
Fecal microbiota transplant protocol for clostridium difficile infection
William M Tauxe1, Tanvi Dhere2, Angela Ward2
1Emory University School of Medicine, Atlanta, Georgia.
Abstract:
Fecal microbiota transplant has become more acceptable as a therapeutic for recurrent Clostridium difficile infection. The FDA has an enforcement discretion policy for practitioner's performing this therapy, which includes informed consent for this experimental treatment. This manuscript describes a typical procedure that can be followed that includes the important aspects of this preparation and treatment.
Insights
Fecal microbiota transplant is a viable therapy for recurrent Clostridium difficile infection. This guide details the preparation and treatment procedures, including FDA-regulated informed consent for this experimental therapy.
Area of Science:
- Microbiology
- Gastroenterology
- Therapeutic Procedures
Background:
- Recurrent Clostridium difficile infection (CDI) presents a significant clinical challenge.
- Fecal microbiota transplant (FMT) is an increasingly accepted therapeutic option for refractory CDI.
- Regulatory bodies, such as the FDA, have established guidelines for FMT, including informed consent.
Purpose of the Study:
- To outline a standardized procedure for performing fecal microbiota transplant.
- To highlight key considerations for the preparation and administration of FMT.
- To ensure compliance with regulatory requirements for experimental therapies.
Main Methods:
- Detailed description of the FMT procedure.
- Emphasis on patient screening and donor selection.
- Inclusion of protocols for sample preparation and delivery.
- Informed consent process for experimental treatment.
Main Results:
- A comprehensive procedural guide for FMT in recurrent CDI.
- Highlights critical steps for successful and safe FMT administration.
- Addresses the importance of informed consent in experimental therapies.
Conclusions:
- Fecal microbiota transplant is a well-defined therapeutic approach for recurrent Clostridium difficile infection.
- Standardized procedures and adherence to FDA guidelines, including informed consent, are crucial for FMT.
- This manuscript provides a practical framework for clinicians performing FMT.
