Characterization of the oral microbiome for the non-invasive diagnosis of barrett's esophagus
Inventors
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Assignees
Columbia University in the City of New York
Member
Columbia UniversityColumbia University is a leading Ivy League research university in New York City, founded in 1754. It comprises undergraduate and graduate programs across 17+ schools, a world-renowned medical center, and nearly 200 research centers and institutes. The Global Alliance for Preventing Pandemics (GAPP) in the Mailman School of Public Health is dedicated to capacity building through workforce development and democratization of technology to provide public health professionals in the Global South every opportunity to independently identify and contain pathogen outbreaks. GAPP focuses on sharing sustainable technologies and best technical practices involving sequencing, serological, and rapid diagnostics tools so public health teams are poised to achieve their very different goals addressing their varied and evolving needs. GAPP works closely with the US CDC, NIAID, WHO, GOARN, foundations dedicated to global health and medical equity, and local and regional ministries of health and education to address human health, and the ministries of livestock and fisheries to help address food security while fostering a culture of the open sharing of data.
Columbia University is a leading Ivy League research university in New York City, founded in 1754. It comprises undergraduate and graduate programs across 17+ schools, a world-renowned medical center, and nearly 200 research centers and institutes. The Global Alliance for Preventing Pandemics (GAPP) in the Mailman School of Public Health is dedicated to capacity building through workforce development and democratization of technology to provide public health professionals in the Global South every opportunity to independently identify and contain pathogen outbreaks. GAPP focuses on sharing sustainable technologies and best technical practices involving sequencing, serological, and rapid diagnostics tools so public health teams are poised to achieve their very different goals addressing their varied and evolving needs. GAPP works closely with the US CDC, NIAID, WHO, GOARN, foundations dedicated to global health and medical equity, and local and regional ministries of health and education to address human health, and the ministries of livestock and fisheries to help address food security while fostering a culture of the open sharing of data.
Publication Number
US-12357595-B2
Publication Date
2025-07-15
Expiration Date
Abstract
The present invention relates to noninvasive microbiome analyses of Barrett's esophagus (BE) patients in which changes in the relative abundance of certain bacteria indicate a disease likelihood or pathogenic state. Additional aspects of the present invention relate to manipulating the microbiome to treat or prevent BE and related conditions. Embodiments also include monitoring for development of disease or monitoring treatment for prevention or elimination of disease states.
Core Innovation
The present invention relates to noninvasive microbiome analyses of Barrett's esophagus (BE) patients in which changes in the relative abundance of certain bacteria indicate a disease likelihood or pathogenic state. Additional aspects of the present invention relate to manipulating the microbiome to treat or prevent BE and related conditions, and embodiments include monitoring for development of disease or monitoring treatment for prevention or elimination of disease states. In certain embodiments, determining the relative abundance of Veillonella dispar, Streptococcus, Lautropia, Enterobacteriaceae, and Lactobacillus in an oral sample is indicative of BE and/or related disorders when compared with an oral sample from a healthy control, and the oral sample is indicative of the oral and/or esophageal microbiota.
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 confers a 30- to 40-fold increased risk of developing esophageal adenocarcinoma (EAC). BE itself exhibits no specific symptoms and a major proportion of patients with BE have no history of GERD, while the only current diagnostic tool is upper endoscopy and biopsy, an invasive, uncomfortable, involved, and expensive procedure, creating a need for the development of a non-invasive, facile diagnostic for BE.
Claims Coverage
Two independent claims are presented, each claiming oral application of an antimicrobial or antiseptic rinse comprising chlorhexidine for distinct purposes.
Oral application of chlorhexidine rinse to treat or prevent BE and related conditions
A method for treating or preventing Barrett's esophagus (BE) and related conditions in a mammal comprising orally applying an antimicrobial or antiseptic rinse to the mammal, wherein the antimicrobial or antiseptic rinse comprises chlorhexidine.
Oral application of chlorhexidine rinse to alter the esophageal microbiome
A method for altering the esophageal microbiome in a mammal comprising orally applying an antimicrobial or antiseptic rinse to the mammal, wherein the antimicrobial or antiseptic rinse comprises chlorhexidine.
The independent claims focus on orally applying an antimicrobial or antiseptic rinse comprising chlorhexidine to a mammal for (1) treating or preventing BE and related conditions and (2) altering the esophageal microbiome.
Stated Advantages
Uses a saliva sample or an oral swab to collect a sample of the patient's microbiome, enabling a non-invasive sample collection.
Relies on the strong correlation of oral and esophageal microbiomes so oral sampling can substitute for invasive esophageal sampling.
Assesses the relative abundance of Streptococcus, Lautropia, Enterobacteriaceae, Veillonella dispar, and Lactobacillus to distinguish BE from non-BE patients, providing a potential non-invasive diagnostic ('BE microbiome signature').
Therapeutic use of an antimicrobial or antiseptic mouth rinse (e.g., chlorhexidine) to alter the oral and esophageal microbiome as a mechanism to treat or prevent BE and related conditions.
Provides a potential monitoring tool for development of disease or monitoring treatment by assessing changes in the oral microbiome.
Documented Applications
Non-invasive detection or diagnosis of Barrett's esophagus (BE) and/or related disorders by determining the relative abundance of Veillonella dispar, Streptococcus, Lautropia, Enterobacteriaceae, and Lactobacillus in an oral sample compared with a healthy control oral sample.
Monitoring treatment of Barrett's esophagus (BE) and related disorders by determining the relative abundance of Veillonella dispar, Streptococcus, Lautropia, Enterobacteriaceae, and Lactobacillus in oral samples.
Treating or preventing Barrett's esophagus (BE) and related disorders by orally applying an antimicrobial or antiseptic rinse comprising chlorhexidine.
Altering the esophageal microbiome in a mammal by orally applying an antimicrobial or antiseptic rinse comprising chlorhexidine.
Administering probiotics or prebiotics, alone or in combination with an antimicrobial rinse, to stimulate or inhibit growth of bacteria under- or over-represented in a subject's microbiota as a method of treating BE and related disorders.
Using the BE microbiome signature as a screening tool for patients (including those with GERD) to non-invasively screen for BE.
Applying the microbiome analysis and BE microbiome signature to related conditions including esophageal cancer, esophageal adenocarcinoma, gastroesophageal reflux disease (GERD), indigestion, and eosinophilic esophagitis.
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