Rankings / Immune & Inflammation

FMT (fecal microbiota transplantation)

Immune & Inflammation · Microbiome transplant

Tier A-

Reviewed by Read Off Label · Last reviewed · How we grade

microbiomeprescription
7.7 / 10
Tier A-
Ev 10 Bn 8 Sf 5

Bottom line

Read Off Label grades FMT (fecal microbiota transplantation) as A- (7.7/10) based on very strong evidence, strong benefit magnitude, and a med-risk safety profile.

FDA approved Rebyota (Nov 2022) and Vowst (Apr 2023) as first standardized microbiota products for recurrent CDI.

Studied, labeled, or reported-use context: Rebyota 150 mL enema once; Vowst 4 capsules daily x3 days — Rx only (OpenBiome closed 2024; now via Rebyota or Vowst); DIY FMT illegal and dangerous; not individualized guidance.

What the evidence says

FDA approved Rebyota (Nov 2022) and Vowst (Apr 2023) as first standardized microbiota products for recurrent CDI. DIY FMT has caused deaths from pathogen transmission. Non-CDI indications remain investigational despite hype. Stool banks closing has limited research FMT access.

Mechanism

Infusion of processed donor stool to restore diversity and specific taxa; lyophilized oral capsules (SER-109/Vowst FDA-approved 2023 for CDI) or traditional colonoscopic/enema delivery; mechanism goes beyond any single strain

Studied, labeled, or reported dose & route

Rebyota 150 mL enema once; Vowst 4 capsules daily x3 days

This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.

Citations

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Common questions

What does the evidence show about FMT (fecal microbiota transplantation)'s effects?
Read Off Label rates the evidence for FMT (fecal microbiota transplantation) as Very Strong and the benefit magnitude as strong, producing an overall grade of A- (7.7/10). FDA approved Rebyota (Nov 2022) and Vowst (Apr 2023) as first standardized microbiota products for recurrent CDI.
What safety findings are reported for FMT (fecal microbiota transplantation)?
FMT (fecal microbiota transplantation) has a med risk profile in the database. Med (infection transmission risk — FDA 2019 alerts after deaths from MDR organisms; long-term effects of microbiome transfer unknown) Legal status: Rx only (OpenBiome closed 2024; now via Rebyota or Vowst); DIY FMT illegal and dangerous.
What doses or routes are reported for FMT (fecal microbiota transplantation)?
Rebyota 150 mL enema once; Vowst 4 capsules daily x3 days This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
How does FMT (fecal microbiota transplantation) work?
Infusion of processed donor stool to restore diversity and specific taxa; lyophilized oral capsules (SER-109/Vowst FDA-approved 2023 for CDI) or traditional colonoscopic/enema delivery; mechanism goes beyond any single strain

This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.