Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

NCT06532734 | Recruiting FDA Device

• 1 other identifier: 24-0349
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors

Conditions

Barrett Esophagus; Anorexia Nervosa, Binge Eating/Purging Type; Rumination; Vomiting; Eating Disorders; Esophageal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Number of patients positive for BE

  Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting a current screening guidelines for BE will test positive for BE

  12 months

Study Arms (1)

AN-BP

individuals with a dx of AN-BP, with a \>5-year history of purging, with a frequency of at least once a day.

Device: EsoGuard

Interventions

EsoGuard DEVICE

device used to collect esophageal cell samples to test for the presence of abnormal cells which may indicate a dx of Barrett's esophagitis.

AN-BP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ACUTE patients with a confirmed dx of AN-BP, with a purging history of \>5 year, with a frequency of purging of at least once a day.

You may qualify if:

• Patients diagnosed with an eating disorder diagnosis that includes purging history
• Ages 18-65
• Purging history =\>5 years
• Purging or rumination at a minimum of once daily upon admission.
• Admission to the ACUTE Center for Eating Disorders and Severe Malnutrition

You may not qualify if:

• Any eating disorder diagnosis that does not include purging behaviors
• Ages under 18 and over 65
• Patients who otherwise meet the current ACG screening guidelines (chronic GERD and 3 or more risk factors for Barrett's mentioned in the Background)
• Received mandated care at time of enrollment
• Inability to consent to participate in the research

Sponsors & Collaborators

• Lucid Diagnostics, Inc.: collaborator
• Denver Health and Hospital Authority: lead

Study Sites (3)

ACUTE Center for Eating Disorders and Severe Malnutrition

Denver, Colorado, 80204, United States

RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

MeSH Terms

Conditions

Barrett Esophagus; Anorexia Nervosa; Bulimia; Rumination Syndrome; Vomiting; Feeding and Eating Disorders; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allison Nitsch, MD

  Denver Health and Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina J Foster, BA

CONTACT

303-602-1913; marina.foster@dhha.org

Allison Nitsch, MD

CONTACT

303-602-5067; Allison.nitsch@dhha.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Hospitalist

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)