Non-invasive oral microbiome diagnostic and chlorhexidine rinse therapy for Barrett's esophagus and related conditions

This technology is a non-invasive test that uses oral microbiome biomarkers to detect Barrett’s esophagus (BE), paired with an oral rinse to help prevent and treat BE and related esophageal disorders.

Unmet Need: Non-invasive early detection and treatment of esophageal diseases

Barrett’s esophagus (BE) is a disease characterized by the replacement of the cell tissue lining of the esophagus with cells more similar to those in the intestine, and can be a serious complication of gastroesophageal reflux disease (GERD). The presence of BE confers a 30- to 40-fold increased risk of developing esophageal adenocarcinoma (EAC), a serious cancer with high mortality rate. Current diagnostic and treatment options for BE require invasive procedures such as upper endoscopy and resection of damaged tissue. As such, there is a clear need for effective, non-invasive approaches for both the diagnosis and treatment of BE and related conditions.

The Technology: Oral microbiome-based diagnosis and treatment of Barrett’s esophagus and related conditions

This technology comprises two components: a biomarker test that noninvasively assesses the oral microbiome to identify bacterial strains involved in the pathogenesis of Barrett’s esophagus (BE) and related conditions, and a therapeutic oral rinse that alters the microbiome to treat or prevent them. Using a saliva sample or oral swab, the test detects, and monitors BE progression by measuring the relative abundance of several bacterial taxa. The oral rinse contains the antiseptic chlorhexidine, which alters the bacterial composition of the esophagus and suppresses invasive, inflammation-causing pathogens. Together, these components offer a non-invasive, cost-effective approach for the diagnosis, prevention, treatment, and monitoring of BE and related esophageal diseases.

This technology has been tested in a clinical cohort of 49 patients and will be assessed in a larger cohort of patients (~1,100) undergoing their first upper endoscopy.

Applications:

• Non-invasive diagnosis of Barrett’s esophagus (BE) via oral microbiome analysis

• Prophylaxis and treatment of BE and related conditions, including esophageal cancer, esophageal adenocarcinoma, gastroesophageal reflux disease (GERD), indigestion, and eosinophilic esophagitis

• Platform to study the pathogenicity of bacterial species involved in BE and esophageal adenocarcinoma

• Platform to study the development of esophageal disorders and esophageal cancer dependent on the presence and levels of bacterial species

• Platform and method of monitoring treatment of BE

Advantages:

• Non-invasive diagnosis and treatment of esophageal diseases

• Enables early detection and disease prevention of esophageal diseases

• Compatible with existing medications targeting reflux and inflammation

• Can be self-administered by the patient

• Screening and treatment do not require in-patient care or a specialized setting

• Cost-effective

Lead Inventor:

Julian Abrams, M.D., M.S.

Patent Information:

Patent Issued (US 12,357,595)

Related Publications:

• Solfisburg QS, Baldini F, Baldwin-Hunter BL, Lee HH, Park H, Freedberg DE, Lightdale CJ, Korem T, Abrams JA. “The salivary microbiome and predicted metabolite production are associated with progression from barett’s esophagus to esophageal adenocarcinoma.” bioRxiv 2023 Jun 28

• Radani N, Metwaly A, Reitmeier S, Baumeister T, Ingermann J, Horstmann J, Anand A, Gatz I, Kohlmayer F, Janssen KP, Slotta-Huspenina J, Schmid RM, Haller D, Abrams JA, Quante M. “Analysis of fecal, salivary, and tissue microbiome in barret’s esophagus, dysplasia, and esophageal adenocarcinoma.” GastroHep Advances 2022 Apr 09;1(5):755-766

• Annavajhala MK, May M, Compres G, Freedberg DE, Graham R, Stump S, Que J, Korem T, Uhlemann AC, Abrams JA. “Relationship of the esophageal microbiome and tissue gene expression and links to the oral microbiome: a randomized clinical trial.” Clin Transl Gastroenterol 2020 Dec;11(12):e00235

• Snider EJ, Compres G, Freedberg DE, Khiabanian H, Nobel YR, Stump S, Uhlemann AC, Lightdale CJ, Abrams JA. “Alterations to the esophageal microbiome associated with progression from barrett’s esophagus to esophageal adenocarcinoma.” Cancer Epidemiol Biomarkers Prev 2019 Oct; 28(10):1687-1693

• Snider EJ, Compres G, Freedberg DE, Giddins MJ, Khiabanian H, Lightdale CJ, Nobel YR, Toussaint NC, Uhlemann AC, Abrams JA. “Barrett’s esophagus is associated with a distinct oral microbiome.” Clin Transl Gastroenterol 2018 Feb 20; 9(3): 135.

Tech Ventures Reference:

• IR CU17016, CU21115

• Licensing Contact: Joan Martinez