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3. Trust Your Gut : Establishing Confidence in Gastrointestinal Models - An Overview of the State of the Science and Contexts of Use

Author

Debad, Susan, Allen, David, Bandele, Omari, Bishop, Colin, Blaylock, Michaela, Brown, Paul, Bunger, Maureen K., Co, Julia Y., Crosby, Lynn, Daniel, Amber B., Ferguson, Steve S., Ford, Kevin, da Costa, Goncalo Gamboa, Gilchrist, Kristin H., Grogg, Matthew W., Gwinn, Maureen, Hartung, Thomas, Hogan, Simon P., Jeong, Ye Eun, Kass, George E. N., Kenyon, Elaina, Kleinstreuer, Nicole C., Kujala, Ville, Lundquist, Patrik, Matheson, Joanna, McCullough, Shaun D., Melton-Celsa, Angela, Musser, Steven, Oh, Ilung, Oyetade, Oluwakemi B., Patil, Sarita U., Petersen, Elijah J., Sadrieh, Nakissa, Sayes, Christie M., Scruggs, Benjamin S., Tan, Yu-Mei, Thelin, Bill, Nelson, M. Tyler, Tarazona, Jose, V, Wambaugh, John F., Yang, Jun-Young, Yu, Changwoo, Fitzpatrick, Suzanne, Debad, Susan, Allen, David, Bandele, Omari, Bishop, Colin, Blaylock, Michaela, Brown, Paul, Bunger, Maureen K., Co, Julia Y., Crosby, Lynn, Daniel, Amber B., Ferguson, Steve S., Ford, Kevin, da Costa, Goncalo Gamboa, Gilchrist, Kristin H., Grogg, Matthew W., Gwinn, Maureen, Hartung, Thomas, Hogan, Simon P., Jeong, Ye Eun, Kass, George E. N., Kenyon, Elaina, Kleinstreuer, Nicole C., Kujala, Ville, Lundquist, Patrik, Matheson, Joanna, McCullough, Shaun D., Melton-Celsa, Angela, Musser, Steven, Oh, Ilung, Oyetade, Oluwakemi B., Patil, Sarita U., Petersen, Elijah J., Sadrieh, Nakissa, Sayes, Christie M., Scruggs, Benjamin S., Tan, Yu-Mei, Thelin, Bill, Nelson, M. Tyler, Tarazona, Jose, V, Wambaugh, John F., Yang, Jun-Young, Yu, Changwoo, and Fitzpatrick, Suzanne

Abstract

The webinar series and workshop titled "Trust Your Gut: Establishing Confidence in Gastrointestinal Models - An Overview of the State of the Science and Contexts of Use" was co-organized by NICEATM, NIEHS, FDA, EPA, CPSC, DoD, and the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) and hosted at the National Institutes of Health in Bethesda, MD, USA on October 11-12, 2023. New approach methods (NAMs) for assessing issues of gastrointestinal tract (GIT)related toxicity offer promise in addressing some of the limitations associated with animal-based assessments. GIT NAMs vary in complexity, from two-dimensional monolayer cell line-based systems to sophisticated 3-dimensional organoid systems derived from human primary cells. Despite advances in GIT NAMs, challenges remain in fully replicating the complex interactions and processes occurring within the human GIT. Presentations and discussions addressed regulatory needs, challenges, and innovations in incorporating NAMs into risk assessment frameworks; explored the state of the science in using NAMs for evaluating systemic toxicity, understanding absorption and pharmacokinetics, evaluating GIT toxicity, and assessing potential allergenicity; and discussed strengths, limitations, and data gaps of GIT NAMs as well as steps needed to establish confidence in these models for use in the regulatory setting.

Published
2024
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6. Identification and Characterization of ten Escherichia coli Strains Encoding Novel Shiga Toxin 2 Subtypes, Stx2n as Well as Stx2j, Stx2m, and Stx2o, in the United States

Author

Lindsey, Rebecca L., primary, Prasad, Arjun, additional, Feldgarden, Michael, additional, Gonzalez-Escalona, Narjol, additional, Kapsak, Curtis, additional, Klimke, William, additional, Melton-Celsa, Angela, additional, Smith, Peyton, additional, Souvorov, Alexandre, additional, Truong, Jenny, additional, and Scheutz, Flemming, additional

Published
2023
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7. Identification and Characterization of ten Escherichia coli Strains encoding Novel Shiga Toxin 2 Subtypes, Stx2n as well as Stx2j, Stx2m, and Stx2o, in the United States

Author

Lindsey, Rebecca L, primary, Prasad, Arjun, additional, Feldgarden, Michael, additional, Gonzalez-Escalona, Narjol, additional, Kapsak, Curtis, additional, Klimke, William, additional, Melton-Celsa, Angela, additional, Smith, Peyton, additional, Souvorov, Alexandre, additional, Truong, Jenny, additional, and Scheutz, Flemming, additional

Published
2023
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14. Clinical isolates of Shiga toxin 1a--producing Shigella flexneri with an epidemiological link to recent travel to Hispaniola

Author

Gray, Miranda D., Lampel, Keith A., Strockbine, Nancy A., Fernandez, Reinaldo E., Melton-Celsa, Angela R., and Maurelli, Anthony T.

Subjects
Identification and classification, Genetic aspects, Research, Health aspects, Genetic toxicology -- Research, Genetic research, Shigella flexneri -- Identification and classification -- Genetic aspects, International travel -- Health aspects
Abstract

Shiga toxins (Stx) are potent AB5 cytotoxins that inhibit eukaryotic protein synthesis, eventually leading to host cell death (1). Infections with bacteria that produce Stx result in hemorrhagic colitis and [...]

Published
2014
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23. A novel murine infection model for Shiga toxin-producing Escherichia coli

Author

Mallick, Emily M., McBee, Megan E., Vanguri, Vijay K., Melton-Celsa, Angela R., Schlieper, Katherine, Karalius, Brad J., O'Brien, Alison D., Butterton, Joan R., Leong, John M., and Schauer, David B.

Subjects
Diagnosis, Care and treatment, Models, Health aspects, Bacterial toxins -- Health aspects, Escherichia coli infections -- Diagnosis -- Care and treatment -- Models
Abstract

Introduction Shiga toxin (Stx) is a potent phage-encoded cytotoxin, and Stx-producing Escherichia coli (STEC) have been implicated in serious outbreaks of food-borne disease. For example, an E. coli serotype O104 [...], Enterohemorrhagic E. coli (EHEC) is an important subset of Shiga toxin-producing (Stx-producing) E. coli (STEC), pathogens that have been implicated in outbreaks of food-borne illness and can cause intestinal and systemic disease, including severe renal damage. Upon attachment to intestinal epithelium, EHEC generates 'attaching and effacing' (AE) lesions characterized by intimate attachment and actin rearrangement upon host cell binding. Stx produced in the gut transverses the intestinal epithelium, causing vascular damage that leads to systemic disease. Models of EHEC infection in conventional mice do not manifest key features of disease, such as AE lesions, intestinal damage, and systemic illness. In order to develop an infection model that better reflects the pathogenesis of this subset of STEC, we constructed an Stx-producing strain of Citrobacter rodentium, a murine AE pathogen that otherwise lacks Stx. Mice infected with Stx-producing C. rodentium developed AE lesions on the intestinal epithelium and Stx-dependent intestinal inflammatory damage. Further, the mice experienced lethal infection characterized by histopathological and functional kidney damage. The development of a murine model that encompasses AE lesion formation and Stx-mediated tissue damage will provide a new platform upon which to identify EHEC alterations of host epithelium that contribute to systemic disease.

Published
2012
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28. Genetic and Virulence Profiles of Enteroaggregative Escherichia coli (EAEC) Isolated From Deployed Military Personnel (DMP) With Travelers' Diarrhea

Author

Petro, Courtney D., primary, Duncan, Jeffrey K., additional, Seldina, Yuliya I., additional, Allué-Guardia, Anna, additional, Eppinger, Mark, additional, Riddle, Mark S., additional, Tribble, David R., additional, Johnson, Ryan C., additional, Dalgard, Clifton L., additional, Sukumar, Gauthaman, additional, Connor, Patrick, additional, Boisen, Nadia, additional, and Melton-Celsa, Angela R., additional

Published
2020
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32. 1169 Travelers' Diarrhea, Single Dose Antibiotics, Acquisition of Multi-Drug Resistance and Associations With Functional Microbiome Characterization: Is There Any There There?

Author

Johnson, Ryan C., primary, Van Nostrand, Joy D., additional, Tisdale, Michele, additional, Swierczewski, Brett E., additional, Simons, Mark P., additional, Connor, Patrick, additional, Fraser, Jamie, additional, Melton-Celsa, Angela R., additional, Tribble, David R., additional, and Riddle, Mark S., additional

Published
2019
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40. Escherichia coli O157:H7 Infection in Dutch Belted and New Zealand White Rabbits

Author

Panda, Aruna, Tatarov, Ivan, Melton-Celsa, Angela R, Kolappaswamy, Krishnan, Kriel, Edwin H, Petkov, Daniel, Coksaygan, Turhan, Livio, Sofie, McLeod, Charles G, Nataro, James P, O'Brien, Alison D, and DeTolla, Louis J

Subjects
Male, Base Sequence, Species Specificity, Rabbit Model, Animals, Rabbits, Escherichia coli O157, Polymerase Chain Reaction, Escherichia coli Infections, DNA Primers
Abstract

Enterohemorrhagic Escherichia coli (EHEC) produce one or more types of Shiga toxins and are foodborne causes of bloody diarrhea. The prototype EHEC strain, Escherichia coli O157:H7, is responsible for both sporadic cases and serious outbreaks worldwide. Infection with E. coli that produce Shiga toxins may lead to diarrhea, hemorrhagic colitis, or (less frequently) hemolytic uremic syndrome, which can cause acute kidney failure. The exact mechanism by which EHEC evokes intestinal and renal disease has not yet been determined. The development of a readily reproducible animal oral-infection model with which to evaluate the full pathogenic potential of E. coli O157:H7 and assess the efficacy of therapeutics and vaccines remains a research priority. Dutch belted (DB) rabbits are reported to be susceptible to both natural and experimental EHEC-induced disease, and New Zealand white (NZW) rabbits are a model for the intestinal manifestations of EHEC infection. In the current study, we compared the pathology caused by E. coli O157:H7 infection in DB and NZW rabbits. Both breeds of rabbits developed clinical signs of disease and intestinal lesions after experimental infection. In addition, one of the infected DB rabbits developed renal lesions. Our findings provide evidence that both breeds are susceptible to E. coli O157:H7 infection and that both may be useful models for investigating EHEC infections of humans.

Published
2010

47. Pathogenesis of Escherichia coli O157:H7 Strain 86-24 Following Oral Infection of BALB/c Mice with an Intact Commensal Flora

Author

NAVAL MEDICAL RESEARCH CENTER SILVER SPRING MD, Mohawk, Krystle L, Melton-Celsa, Angela R, Zangari, Tonia, Carroll, Erica E, O'Brien, Alison D, NAVAL MEDICAL RESEARCH CENTER SILVER SPRING MD, Mohawk, Krystle L, Melton-Celsa, Angela R, Zangari, Tonia, Carroll, Erica E, and O'Brien, Alison D

Abstract

Escherichia coli 0 157:H7 is a food-borne pathogen that can cause hemorrhagic colitis and. occasionally. hemolytic uremic syndrome, a sequela of infection that can result in renal failure and death. Here we sought to model the pathogenesis of orally-administered E. coli 0157:H7 in BALB/c mice with an intact intestinal nora. First. we defined the optimal dose that permitted sustained fecal shedding of E. coli 0157:H7 over 7 days ( -109 colony forming units). Next. we monitored the load of E. coli 0157:H7 in intestinal sections over time and observed that the cecum was consistently the tissue with the highest E. coli 0157: H7 recovery. We then followed the expression of two key E. coli 0 157:H7 virulence factors. the adhesin intimin and Shiga toxin type 2, and detected both proteins early in infection when bacterial burdens were highest. Additionally, we noted that during infection, animals lost weight and - 30% died. Moribund animals also exhibited elevated levels of blood urea nitrogen. and. on necropsy, showed evidence of renal tubular damage. We conclude that conventional mice inoculated orally with high doses of E. coli 0 157:H7 can be used to model both intestinal colonization and subsequent development of certain extraintestinal manifestations of E. coli 0157:H7 disease., Pub. in Microbial Pathogenesis, v48, p131 - 142, 2010.

Published
2010

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