Review Article

Genetically Engineered Microorganisms and Their Impact on Human Health

Table 3

Genetically modified microorganisms in different clinical trial stages.

ConditionEngineered microorganismsTargetClinical trial codeClinical trial phaseStatus

Metabolic diseasesE. coli (SYNB1934 and SYNB1618)PhenylketonuriaNCT04984525Phase 1Ongoing
Metabolic diseasesE. coli (SYNB8802)Enteric hyperoxaluriaNCT04629170Phase 1Ongoing
CancerE. coli (SYNB1891)Metastatic solid Neoplasm and LymphomaNCT04167137Phase 1Ongoing
CancerB. longum (bacTRL-IL-12)Solid tumorsNCT04025307Phase 1Ongoing
Metabolic diseasesE. coli (SYNB1618)PhenylketonuriaNCT03516487Phase 1/2aOngoing
Metabolic diseasesBacteroides (NB1000S)Enteric hyperoxaluriaNCT04909723Phase 1/2aOngoing
CancerB. longum (APS001F)Solid tumorNCT01562626Phase 1/2Ongoing
CancerB. animalis lactis (EDP1503)Colorectal cancer and checkpoint inhibitor relapsed tumorsNCT03775850Phase 1/2Done
DiseaseL. lactis (AG011)Moderately active ulcerative colitisNCT00729872Phase 1/2Done
Metabolic diseasesE. coli (SYNB1020)Cirrhosis and hyperammonemiaNCT03447730Phase 1/2Done
Metabolic diseasesL. lactis (AG019)Type 1 diabetesNCT03751007Phase 1/2Ongoing
InfectionL. lactis (AG013)Oral mucositisNCT03234465Phase 2Done
InfectionL. crispatus (LACTIN-V, Osel, Inc.)Bacterial vaginosisNCT02766023Phase 2Done
InfectionL. crispatus (LACTIN-V)Urinary tract infectionNCT00305227Phase 2Done
DiseasesL. rhamnosus GG (LGG)GastroenteritisNCT01773967Phase 2/3Done
InfectionSalmonella (Vivotif)S. typhiSTN:103123License
InfectionVibrio cholerae (Vaxchora)V. cholerae serogroup O1STN:125597License
CancerSalmonella (VNP20009)Cancer neoplasm, neoplasm, metastasisNCT00004988Phase 1Done
CancerSalmonella (VNP20009)Advanced solid tumorsNCT00006254Phase 1Done
CancerIL-2 expressing, attenuated Salmonella typhimuriumUnresectable hepatic metastasisNCT01099631Phase 1Ongoing
Metabolic diseasesE. coli (SYNB1020)Urea cycle disorderNCT03179878Phase 1Done
CancerE. coli bacterial minicell (VAX014)Urothelial carcinoma of the urinary bladderNCT03854721Phase 1Ongoing
CancerClostridium novyi-NTsporesMalignant neoplasm of breast or digestive organs, etcNCT03435952Phase 1Ongoing
CancerClostridium novyi-NTsporesSolid tumor malignanciesNCT01924689Phase 1Done
CancerSalmonella (VXM01)Recurrent glioblastomaNCT03750071Phase 1/2Ongoing
CancerListeria monocytogenes (ADXS31-142 + Pembrolizumab)Cancer prostate cancerNCT02325557Phase 1/2Ongoing
CancerListeria monocytogenes (CRS-207)Pancreatic cancerNCT03190265Phase 2Ongoing
InfectionE. coli (ACE527)DiarrheaNCT03179878Phase 1/2Done
Metabolic diseasesCutaneous microbiota (STMC-103)Atopic immunoglobulin e-mediated allergic disorderNCT03819881Phase 1bUnknown
CancerMRx0518+PembrolizumabNon-small-cell lung cancer, renal cell carcinoma, melanomaNCT03637803Phase 1/2Ongoing
CancerVE800+NivolumabMetastatic cancerNCT04208958Phase 1/2Ongoing
InfectionOral full-spectrum microbiota (CP101)C. difficile infection recurrenceNCT03110133Phase 2Done
Metabolic diseasesFull spectrum microbiota (FSM)Autism spectrum disorder, gastrointestinal disorderNCT03408886Phase 2Ongoing
DiseaseDS-01Irritable bowel syndromeNCT04598295Phase 2Unknown
Metabolic diseasesMaaT013Gastrointestinal acute graft vs host diseaseNCT03359980Phase 2Done
InfectionVE303C. difficile infection recurrenceNCT03788434Phase 2Done
InfectionSER-109 (purified Firmicutes spores)C. difficile infectionNCT03183141Phase 3Done
InfectionRBX2660C. difficile infectionNCT03244644Phase 3Done

Bifidobacterium animalis: B. animalis; Lactobacillus crispatus: L. crispatus.