Table 2.
Comparison of the various forms of bacteriotherapy available, fecal microbiota transplantation, and newly licensed live biotherapeutic products.
| Product type, company, name | How to access | Pre-treatment bowel prep needed | Treatment type and regimen | Product characterization pre-treatment | Cost | Efficacy a in published studies |
|---|---|---|---|---|---|---|
| Investigational FMT OpenBiome FMT (two concentrations) |
Find a physician in a zip code by searching OpenBiome.org/find-a-doctor | Bowel prep for colonoscopy/sigmoidoscopy administration | Solution: One infusion by colonoscopy/sigmoidoscopy or by nasogastric tube | No | $1695 for either preparation plus $150 for shipping | In 267 patients blinded to treatment, cure was seen in 70.4% given RBX2660 and 58.1% in placebo (posterior probability value of superiority of 0.991). 28 |
| Investigational FMT OpenBiome through the AGA FMT |
By application through https://gastro.org/research-and-awards/registries-and-studies/fecal-microbiota-transplantation-national-registry/ | Bowel prep for colonoscopy/sigmoidoscopy administration | Solution: One infusion by colonoscopy/sigmoidoscopy or by nasogastric tube | No | No cost for product, only administration should be covered by insurance | |
| FDA-approved (licensed) treatment LBP Ferring Pharmaceuticals RBX2660 (Rebyota™) generic name, fecal microbiota, live-jslm |
Prescription from a physician | None | Solution: One enema of 150 mL of product | Yes | $9000 Covered by most insurance plans |
Clinical response was defined as no recurrence of CDI during the 8 weeks post-treatment, which was seen in 71% randomized to the fecal microbiota, live-jslm-treated groups compared with a cure rate in the placebo groups of 58%. 31 |
| FDA-approved (licensed) treatment LBT Seres Pharmaceuticals and Nestle SER-109 (VOWST), generic name fecal microbiota spores, live-brpk |
Prescription from a physician | Magnesium citrate 10 oz the day before | Capsules: four capsules/day for 3 days on an empty stomach | Yes | $17,500 Covered by most insurance plans |
In an intent-to-treat analysis of 182 subjects with rCDI, 78/89 (88%) randomized to SER-109 were protected from subsequent bouts of CDI compared with 56/93 (60%) randomized to placebo (p < 0.001). 37 |
a
Rate of prevention of rCDI in treated patients in a placebo-controlled trial; note that the methods differed in the various LBP trials.
AGA, American Gastroenterological Association; FDA, Food and Drug Administration; FMT, fecal microbiota transplantation; rCDI, recurrent Clostridioides difficile infection, LBT, live biotherapeutic products.