Focus of the Report: The focus of this Health Technology Assessment is to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) to treat patients with Crohn disease (CD).

Technology Description: FMT is a procedure by which processed stool from healthy donors is infused into a patient’s gastrointestinal (GI) system for the purpose of treating a disease associated with impaired gut microbiota. Methods used for FMT are not standardized, and routes of administration include endoscopically placed nasoduodenal tube, retention enema, and colonoscopy.

Controversy: Whereas FMT is an established treatment modality for patients with recurrent CDI, any role that FMT might have in the treatment of patients with CD has not been well defined in clinical studies. Controversial issues related to FMT in CD include patient selection, donor selection, stool processing, dosing, route of administration, and frequency of treatment.

Key Questions:

  • Is fecal microbiota transplantation (FMT) effective in treating patients with Crohn disease (CD)?

  • How does FMT compare with other treatments for CD?

  • Is FMT safe in patients with CD?

  • Have definitive patient selection criteria been identified for FMT in patients with CD?

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