Novel Oral Sorbent Therapy for the Prevention and Treatment of Traveler’s Diarrhea

We propose a novel oral technology for the treatment of traveler’s diarrhea (TD). TD is often caused by enteric bacteria that secrete endotoxins. In the gut, these toxins can cause the severe symptoms seen in TD, including pain, cramping, and voluminous diarrhea that can eventually lead to dehydration. The proposed solution binds to and sequesters the bacterial toxins that directly cause the symptoms. The therapy can be taken either preventively, before symptoms begin, or at the onset of symptoms. The therapy is dry, meaning it is lightweight and extremely stable, and thus suitable for use in front line or austere environments and can be easily stockpiled. The treatment can be self-administered – a small packet of only a few grams can be mixed with drinking water and taken orally. The treatment is not pathogen-specific, meaning it can be used to treat or prevent TD caused by a broad variety of pathogens. In Phase I, we will conduct a search for AF end-users. Our Phase II efforts will include an in vivo efficacy study in a highly translationally relevant model system of TD. The system, Aotus monkeys infected with one or more of the pathogens that cause TD (e.g., enterotoxigenic E. coli, Shigella, or Campylobacter), is well-established in the lab of our collaborators. The system is frequently used in DoD studies on the development of vaccines for the prevention of TD. Importantly, our therapy is compatible with vaccines, antibody-mediated therapies, over-the-counter remedies, and the use of antibiotics, meaning it can integrate well with current standard of care and with other DoD efforts to address this problem.