In the Journals

International consensus provides guidance on role of stool banks

Monika Fischer
Monika Fischer

Experts on fecal microbiota transplantation from Europe, North America and Australia have released a new consensus report that provides guidance on how to establish, operate and regulate stool banks.

Monika Fischer, MD, MS, a gastroenterologist at Indiana University Health, told Healio Gastroenterology and Liver Disease that the group made up of more than 30 experts began planning more than a year ago. They sought to build on previous FMT guidelines by providing recommendations specifically to address the operation of stool banks and the distribution of fecal samples.

Although the process began before FDA issued a safety alert for FMT after a patient died, Fischer said the issue brings the consensus report’s importance into focus. As FMT becomes more common, the need for well-regulated and well-operated stool banks has become clear, she said.

“It is widely accepted that FMT is now a mainstream therapy for refractory, recurrent [Clostridioides difficile], but stool-related products should be prepared just like blood-related products in terms of rigorous donor testing, material handling and storage,” she said. “The best place for that is a stool bank.”

To build the report, the experts created and debated more than 80 statements. To be included in the report, more than 80% of the participants had to agree on a statement or modify it until it was acceptable. They also graded the evidence for the recommendations and decided if they were “strong” or “weak.”

The recommendations were broken down into six working groups:

General principles

The first group of statements are focused on the organization of stool banks, including security measures, necessary qualifications for directors and regulations. Specifically, stool banks should undergo approval from the relevant national regulatory agency in each country.

Selecting, screening donors

Fischer said this was the most extensively debated group. The experts agreed that stool donors should complete a medical history questionnaire and undergo blood and stool testing before they are approved for donation. Repeat donors should also undergo clinical assessment and lab testing every 8 to 12 weeks.

Collecting, preparing, storing feces

This group of statements addressed how stool banks should collect and store feces at their facility and includes recommendations on proper labeling and temperature control. The experts also agreed that donated samples should be kept for no more than 2 years.

Services, clients

The experts provided detailed instructions on how stool banks should make fecal samples available for treatment. This includes recommendations for how health care facilities should handle, store and administer fecal samples. They also make it clear that samples cannot be provided directly to patients.

Registries, monitoring outcomes and ethical issues

To track and ensure patient safety, the experts agreed that donor records, as well as a portion of each sample, should be kept in the case of adverse events. They also suggested that practitioners of FMT should monitor patients for severe adverse events and believe that recipient registries may help monitor incidents of adverse events.

Evolving role of FMT

The consensus group ended by acknowledging FMT’s role as an important therapy for recurrent C. diff and an option in patients with fulminant C. diff. While it is seen as potential therapy in other diseases, like ulcerative colitis, future studies are needed before it is considered ready for clinical practice. by Alex Young

Disclosures: Fischer reports serving as a consultant for Finch Therapeutics group, an unpaid advisor for OpenBiome and being a safety monitoring board member for Rebiotix. Please see the full study for all other authors’ relevant financial disclosures.

Monika Fischer
Monika Fischer

Experts on fecal microbiota transplantation from Europe, North America and Australia have released a new consensus report that provides guidance on how to establish, operate and regulate stool banks.

Monika Fischer, MD, MS, a gastroenterologist at Indiana University Health, told Healio Gastroenterology and Liver Disease that the group made up of more than 30 experts began planning more than a year ago. They sought to build on previous FMT guidelines by providing recommendations specifically to address the operation of stool banks and the distribution of fecal samples.

Although the process began before FDA issued a safety alert for FMT after a patient died, Fischer said the issue brings the consensus report’s importance into focus. As FMT becomes more common, the need for well-regulated and well-operated stool banks has become clear, she said.

“It is widely accepted that FMT is now a mainstream therapy for refractory, recurrent [Clostridioides difficile], but stool-related products should be prepared just like blood-related products in terms of rigorous donor testing, material handling and storage,” she said. “The best place for that is a stool bank.”

To build the report, the experts created and debated more than 80 statements. To be included in the report, more than 80% of the participants had to agree on a statement or modify it until it was acceptable. They also graded the evidence for the recommendations and decided if they were “strong” or “weak.”

The recommendations were broken down into six working groups:

General principles

The first group of statements are focused on the organization of stool banks, including security measures, necessary qualifications for directors and regulations. Specifically, stool banks should undergo approval from the relevant national regulatory agency in each country.

Selecting, screening donors

Fischer said this was the most extensively debated group. The experts agreed that stool donors should complete a medical history questionnaire and undergo blood and stool testing before they are approved for donation. Repeat donors should also undergo clinical assessment and lab testing every 8 to 12 weeks.

Collecting, preparing, storing feces

This group of statements addressed how stool banks should collect and store feces at their facility and includes recommendations on proper labeling and temperature control. The experts also agreed that donated samples should be kept for no more than 2 years.

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Services, clients

The experts provided detailed instructions on how stool banks should make fecal samples available for treatment. This includes recommendations for how health care facilities should handle, store and administer fecal samples. They also make it clear that samples cannot be provided directly to patients.

Registries, monitoring outcomes and ethical issues

To track and ensure patient safety, the experts agreed that donor records, as well as a portion of each sample, should be kept in the case of adverse events. They also suggested that practitioners of FMT should monitor patients for severe adverse events and believe that recipient registries may help monitor incidents of adverse events.

Evolving role of FMT

The consensus group ended by acknowledging FMT’s role as an important therapy for recurrent C. diff and an option in patients with fulminant C. diff. While it is seen as potential therapy in other diseases, like ulcerative colitis, future studies are needed before it is considered ready for clinical practice. by Alex Young

Disclosures: Fischer reports serving as a consultant for Finch Therapeutics group, an unpaid advisor for OpenBiome and being a safety monitoring board member for Rebiotix. Please see the full study for all other authors’ relevant financial disclosures.

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