[Fecal microbiota transplantation: indications, risks and opportunities]

Area of Science:

• Microbiology
• Gastroenterology
• Pharmacology

Background:

• Fecal microbiome transfer (FMT) is utilized in Germany for clinical studies and individual treatments.
• FMT demonstrates efficacy for recurrent Clostridium difficile infection and ulcerative colitis.
• The COVID-19 pandemic highlights pathogen transmission risks, necessitating stringent safety protocols.

Purpose of the Study:

• To review the medico-legal framework and regulatory considerations for FMT in Germany.
• To address challenges related to FMT's drug classification and manufacturing standards.
• To explore future research directions for identifying active microbiome components and recombinant production.

Main Methods:

• Review of current clinical practices and regulatory guidelines for FMT in Germany.
• Analysis of medico-legal implications concerning the classification of the microbiome as a drug.
• Discussion of pandemic-related risks and notification obligations for FMT procedures.

Main Results:

• FMT is recognized as an effective therapy for specific conditions like C. difficile infection and ulcerative colitis.
• In Germany, FMT is regulated as a drug under the Medicines Act, requiring adherence to manufacturing standards and risk information.
• Notification to state authorities is mandatory for FMT in individual treatment attempts.

Conclusions:

• FMT is a proven therapeutic principle for certain gastrointestinal conditions.
• The regulatory landscape in Germany classifies FMT as a drug, emphasizing manufacturing controls and safety.
• Future research focuses on isolating active microbiome components for recombinant production to overcome limitations of current FMT practices.