| Company . | Strain (engineered function) . | API ID . | Disease . | Ph. . | Trial ID (start year, status) . | Dose (CFU) . | Freq. . | Len. . | Form. . |
|---|---|---|---|---|---|---|---|---|---|
| Engineered microorganisms | |||||||||
| Adhera | Escherichia coli (β-catenin shRNA delivery) | CEQ508 | FAP | 1 | START-FAP (2010, comp.) | 108–109 | 1/d | 28 d | - |
| Synlogic | E. coli (NH3 scavenging) | SYNB1020 | UCD | 1 | NCT03179878 (2017, comp.) | 2 × 109–2 × 1012 | 1–3/d | 1–14 d | Susp. |
| Cirrhosis | 1/2 | NCT03447730 (2018, rec.) | 5 × 1011 | 3/d | 6 d | ||||
| E. coli (Phe scavenging) | SYNB1618 | PKU | 1/2 | NCT03516487 (2018, rec.) | 1010–5 × 1011 | 3/d | 1–7 d | ||
| ActoBio | Lactococcus lactis (proinsulin and IL-10 secretion) | AG019/tep | T1D | 1/2 | NCT03751007 (2018, rec.) | 2–6 cap. | 1/d | 1 d–8 wk | Cap. |
| Oragenics | L. lactis (hTFF1 secretion) | AG013 | OM | 1 | NCT00938080 (2009, comp.) | 2 × 1011–1.2 × 1012 | 1–6/d | 14 d | Susp. |
| 2 | NCT03234465 (2017, rec.) | 2 × 1011 | 3/d | 7–9 wk | |||||
| Single defined microorganisms | |||||||||
| Osel | Clostridium butyricum | CBM588 | CDI | 2 | NCT01077245 (2010, with.) | 2 g | 2/d | 42 d | Gran. |
| IBT | Lactobacillus reuteri | IBP-9414 | NEC | 2 | NCT02472769 (2015, comp.) | 108–109 | 1/d | 14 d | Susp. |
| Evelo | Commensal strain | EDP1815 | Psoriasis and eczema | 1 | NCT03733353 (2018, rec.) | 55 mg–2.76 g | 1/d | 15 d | Cap. |
| EDP1066 | 1 | NCT03542994 (2018, rec.) | 66 mg–3.3 g | 1/d | 15 d | ||||
| EDP1503/pem | CRC, TNBC, ICI relapse | 1/2 | NCT03775850 (2018, rec.) | 7.5 × 1010 | 2/d | 14 d | |||
| Melanoma | 2 | NCT03595683 (2018, rec.) | 7.5 × 1010 | 2/d | 14 d | ||||
| 4D Pharma | Bacteroides thetaiotaomicron | Thetanix | CD | - | NCT02704728 (2016, comp.) | 3 cap. | 2/d | 7.5 d | Cap. |
| Enterococcus gallinarum | MRx0518/pem | Solid tumor | 1/2 | NCT03637803 (2018, rec.) | 1 cap. | 2/d | 2 yr | ||
| Blautia hydrogenotrophica | Blautix | IBS | 2 | NCT03721107 (2018, rec.) | >1010 (2 cap.) | 2/d | 8 wk | ||
| Bifidobacterium breve | MRx0004 | Asthma | 1/2 | NCT03851250 (2019, n.rec.) | 109–1010 (2 cap.) | 2/d | 12 wk | ||
| Multiple defined microorganisms | |||||||||
| Leadiant | Lactobacillus acidophilus and Bifidobacterium lactis | STP-206 | NEC | 1 | NCT00922324 (2009, comp.) | - | 1/d | 1–7 d | - |
| 1/2 | NCT01954017 (2013, com.) | - | 1/d | 2–11 wk | - | ||||
| Seres | Firmicute spores | SER-262 | CDI | 1 | NCT02830542 (2016, active) | 104–108 | 1/d | 1 d | C.susp. |
| Vedanta | Eight strains | VE303 | CDI | 2 | NCT03788434 (2018, rec.) | 2–10 cps | 1/d | 14 d | Cap. |
| Siolta | Consortium | STMC-103H | IgE-AD | 1 | NCT03819881 (2019, rec.) | - | 2/d | 28 d | - |
| NuBiyota | ∼30 commensal strains | MET-2 | CDI | 1 | NCT02865616 (2016, rec.) | 1.5–10 g (3–20 cap.) | 1/d | 2–10 d | Cap. |
| UC | 1 | NCT03832400 (2019, rec.) | 1/d | 4–14 d | |||||
| MET-3 | Obesity | e1 | NCT03660748 (2018, rec.) | - | - | - | |||
| MET-4 | LA-OPSCC | - | NCT03838601 (2019, n.rec.) | - | - | 2 d–4 wk | |||
| MET-4/ICI | Solid tumor | e1 | NCT03686202 (2018, rec.) | - | 1/d | >2 d | |||
| Purified fecal microbiota | |||||||||
| Seres | Firmicute spores | SER-287 | UC | 1 | NCT02618187 (2015, comp.) | - | 1/d–1/wk | 8 wk | C.susp. |
| 2 | NCT03759041 (2018, rec.) | - | 1/d | 10 wk | |||||
| SER-109 | CDI | 2 | NCT02437487 (2015, comp.) | 108 (4 cap.) | 1/d | 1 d | |||
| 3 | NCT03183128 (2017, rec.) | - | 4/d | 3 d | |||||
| Fecal microbiota | |||||||||
| MaaT | Donor derived | MaaT013 | GVHD | 2 | NCT03359980 (2017, rec.) | 1012 | 1/d | 3×/16 d | Enema |
| FMT | ICU patients | 2 | NCT03350178 (2017, term.) | - | - | - | |||
| Autologous | FMT | AML | 2 | NCT02928523 (2016, comp.) | 1012 | 1/d | 2 d | ||
| Finch | Donor derived | CP101 | CDI | 2 | NCT03110133 (2017, rec.) | - | 1/d | 1 d | Cap. |
| ASD | 2 | NCT03829878 (2019, n.rec.) | - | 1/d | 1 d | ||||
| oral FMT | CRE | e1 | NCT03527056 (2018, n.rec.) | - | 1/d | 1 d | |||
| Rebiotix | Donor derived | RBX2660 | CDI | 2 | NCT01925417 (2013, comp.) | >1.5 × 109 | 1/d | 1 d | Enema |
| 2 | NCT02299570 (2014, comp.) | - | 1/d | 2×/7 d | |||||
| 2 | NCT02589847 (2015, active) | - | 1/d | 2×/7 d | |||||
| 3 | NCT03244644 (2017, rec.) | - | - | - | |||||
| UTI | 1/2 | NCT03367910 (2017, inv.) | - | 1/d | 1 d | ||||
| HE | 1/2 | NCT03439982 (2018, rec.) | - | - | - | ||||
| RBX7455 | CDI | 1 | NCT02981316 (2016, active) | 1–4 cap. | 2/d | 2–4 d | Cap. | ||
| Company . | Strain (engineered function) . | API ID . | Disease . | Ph. . | Trial ID (start year, status) . | Dose (CFU) . | Freq. . | Len. . | Form. . |
|---|---|---|---|---|---|---|---|---|---|
| Engineered microorganisms | |||||||||
| Adhera | Escherichia coli (β-catenin shRNA delivery) | CEQ508 | FAP | 1 | START-FAP (2010, comp.) | 108–109 | 1/d | 28 d | - |
| Synlogic | E. coli (NH3 scavenging) | SYNB1020 | UCD | 1 | NCT03179878 (2017, comp.) | 2 × 109–2 × 1012 | 1–3/d | 1–14 d | Susp. |
| Cirrhosis | 1/2 | NCT03447730 (2018, rec.) | 5 × 1011 | 3/d | 6 d | ||||
| E. coli (Phe scavenging) | SYNB1618 | PKU | 1/2 | NCT03516487 (2018, rec.) | 1010–5 × 1011 | 3/d | 1–7 d | ||
| ActoBio | Lactococcus lactis (proinsulin and IL-10 secretion) | AG019/tep | T1D | 1/2 | NCT03751007 (2018, rec.) | 2–6 cap. | 1/d | 1 d–8 wk | Cap. |
| Oragenics | L. lactis (hTFF1 secretion) | AG013 | OM | 1 | NCT00938080 (2009, comp.) | 2 × 1011–1.2 × 1012 | 1–6/d | 14 d | Susp. |
| 2 | NCT03234465 (2017, rec.) | 2 × 1011 | 3/d | 7–9 wk | |||||
| Single defined microorganisms | |||||||||
| Osel | Clostridium butyricum | CBM588 | CDI | 2 | NCT01077245 (2010, with.) | 2 g | 2/d | 42 d | Gran. |
| IBT | Lactobacillus reuteri | IBP-9414 | NEC | 2 | NCT02472769 (2015, comp.) | 108–109 | 1/d | 14 d | Susp. |
| Evelo | Commensal strain | EDP1815 | Psoriasis and eczema | 1 | NCT03733353 (2018, rec.) | 55 mg–2.76 g | 1/d | 15 d | Cap. |
| EDP1066 | 1 | NCT03542994 (2018, rec.) | 66 mg–3.3 g | 1/d | 15 d | ||||
| EDP1503/pem | CRC, TNBC, ICI relapse | 1/2 | NCT03775850 (2018, rec.) | 7.5 × 1010 | 2/d | 14 d | |||
| Melanoma | 2 | NCT03595683 (2018, rec.) | 7.5 × 1010 | 2/d | 14 d | ||||
| 4D Pharma | Bacteroides thetaiotaomicron | Thetanix | CD | - | NCT02704728 (2016, comp.) | 3 cap. | 2/d | 7.5 d | Cap. |
| Enterococcus gallinarum | MRx0518/pem | Solid tumor | 1/2 | NCT03637803 (2018, rec.) | 1 cap. | 2/d | 2 yr | ||
| Blautia hydrogenotrophica | Blautix | IBS | 2 | NCT03721107 (2018, rec.) | >1010 (2 cap.) | 2/d | 8 wk | ||
| Bifidobacterium breve | MRx0004 | Asthma | 1/2 | NCT03851250 (2019, n.rec.) | 109–1010 (2 cap.) | 2/d | 12 wk | ||
| Multiple defined microorganisms | |||||||||
| Leadiant | Lactobacillus acidophilus and Bifidobacterium lactis | STP-206 | NEC | 1 | NCT00922324 (2009, comp.) | - | 1/d | 1–7 d | - |
| 1/2 | NCT01954017 (2013, com.) | - | 1/d | 2–11 wk | - | ||||
| Seres | Firmicute spores | SER-262 | CDI | 1 | NCT02830542 (2016, active) | 104–108 | 1/d | 1 d | C.susp. |
| Vedanta | Eight strains | VE303 | CDI | 2 | NCT03788434 (2018, rec.) | 2–10 cps | 1/d | 14 d | Cap. |
| Siolta | Consortium | STMC-103H | IgE-AD | 1 | NCT03819881 (2019, rec.) | - | 2/d | 28 d | - |
| NuBiyota | ∼30 commensal strains | MET-2 | CDI | 1 | NCT02865616 (2016, rec.) | 1.5–10 g (3–20 cap.) | 1/d | 2–10 d | Cap. |
| UC | 1 | NCT03832400 (2019, rec.) | 1/d | 4–14 d | |||||
| MET-3 | Obesity | e1 | NCT03660748 (2018, rec.) | - | - | - | |||
| MET-4 | LA-OPSCC | - | NCT03838601 (2019, n.rec.) | - | - | 2 d–4 wk | |||
| MET-4/ICI | Solid tumor | e1 | NCT03686202 (2018, rec.) | - | 1/d | >2 d | |||
| Purified fecal microbiota | |||||||||
| Seres | Firmicute spores | SER-287 | UC | 1 | NCT02618187 (2015, comp.) | - | 1/d–1/wk | 8 wk | C.susp. |
| 2 | NCT03759041 (2018, rec.) | - | 1/d | 10 wk | |||||
| SER-109 | CDI | 2 | NCT02437487 (2015, comp.) | 108 (4 cap.) | 1/d | 1 d | |||
| 3 | NCT03183128 (2017, rec.) | - | 4/d | 3 d | |||||
| Fecal microbiota | |||||||||
| MaaT | Donor derived | MaaT013 | GVHD | 2 | NCT03359980 (2017, rec.) | 1012 | 1/d | 3×/16 d | Enema |
| FMT | ICU patients | 2 | NCT03350178 (2017, term.) | - | - | - | |||
| Autologous | FMT | AML | 2 | NCT02928523 (2016, comp.) | 1012 | 1/d | 2 d | ||
| Finch | Donor derived | CP101 | CDI | 2 | NCT03110133 (2017, rec.) | - | 1/d | 1 d | Cap. |
| ASD | 2 | NCT03829878 (2019, n.rec.) | - | 1/d | 1 d | ||||
| oral FMT | CRE | e1 | NCT03527056 (2018, n.rec.) | - | 1/d | 1 d | |||
| Rebiotix | Donor derived | RBX2660 | CDI | 2 | NCT01925417 (2013, comp.) | >1.5 × 109 | 1/d | 1 d | Enema |
| 2 | NCT02299570 (2014, comp.) | - | 1/d | 2×/7 d | |||||
| 2 | NCT02589847 (2015, active) | - | 1/d | 2×/7 d | |||||
| 3 | NCT03244644 (2017, rec.) | - | - | - | |||||
| UTI | 1/2 | NCT03367910 (2017, inv.) | - | 1/d | 1 d | ||||
| HE | 1/2 | NCT03439982 (2018, rec.) | - | - | - | ||||
| RBX7455 | CDI | 1 | NCT02981316 (2016, active) | 1–4 cap. | 2/d | 2–4 d | Cap. | ||
Ph., clinical trial phase; Freq., dosing frequency; Len., dosing length; Form., formulation; hTFF1, human trefoil factor 1; tep, teplizumab; pem, pembrolizumab; FAP, familial adenomatous polyposis; UCD, urea cycle disorders; PKU, phenylketonuria; T1D, diabetes mellitus, type 1; OM, oral mucositis; CDI, C. difficile infection; NEC, necrotizing enterocolitis; CRC, colorectal cancer; TNBC, triple-negative breast cancer; ICI, immune checkpoint inhibitors; CD, Crohn’s disease; IBS, irritable bowel syndrome; IgE-AD, atopic immunoglobulin E-mediated allergic disorder; UC, ulcerative colitis; LA-OPSCC, head/neck squamous cell carcinoma; GVHD, graft vs. host disease; ICU, intensive care unit; AML, acute myeloid leukemia; ASD, autism spectrum disorders; CRE, carbapenem-resistant Enterobacteriaceae; UTI, urinary tract infection; HE, hepatic encephalopathy; e, early; comp., completed; rec., recruiting; with., withdrawn; n.rec., not yet recruiting; ter., terminated; inv., enrollment by invitation; susp., suspension; cap., capsule; gran., granules; c.susp., encapsulated suspension.