Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06532734

Presence of Barrett's Esophagitis in a Cohort of People With Eating Disorders Who Engage in Purging Behaviors: A Pilot Study

Led by Denver Health and Hospital Authority · Updated on 2025-12-10

25

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Denver Health and Hospital Authority

Lead Sponsor

L

Lucid Diagnostics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the presence of Barrett's esophagus (BE) in individuals with eating disorders that include purging behaviors such as vomiting or rumination. This observational study aims to better understand how BE may occur in a younger population with severe eating disorders who do not meet the usual screening guidelines for this condition. The study focuses on those with a history of purging lasting at least five years and occurring daily. Participants will be individuals diagnosed with anorexia nervosa binge/purge subtype (AN-BP) who have purging behaviors at least once per day for more than five years. The study uses a device called EsoGuard to collect esophageal cell samples without the need for endoscopy. This device helps detect abnormal cells that could indicate Barrett's esophagitis. The study is conducted over a 12-month period to assess the number of patients testing positive for BE. During the study, participants admitted to the ACUTE Center for Eating Disorders and Severe Malnutrition will undergo non-endoscopic testing with EsoGuard. Researchers will collect and analyze esophageal cell samples to identify abnormal changes. Participants will be monitored and assessed throughout the 12 months to measure the presence of BE. This study does not involve treatment but focuses on detecting Barrett's esophagus in this specific patient group to better inform future screening practices.

CONDITIONS

Brief Title

Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with an eating disorder that includes purging behavior
  • Age between 18 and 65 years
  • History of purging for 5 years or longer
  • Purging or rumination occurring at least once daily upon admission
  • Admission to the ACUTE Center for Eating Disorders and Severe Malnutrition
Not Eligible

You will not qualify if you...

  • Eating disorder diagnosis without purging behaviors
  • Age under 18 or over 65 years
  • Meeting current ACG screening guidelines for Barrett's esophagus (chronic GERD and 3 or more risk factors)
  • Receiving mandated care at time of enrollment
  • Unable to consent to participate in the research

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At enrollment

Participants undergo testing with the EsoGuard device to collect esophageal cell samples to check for the presence of Barrett's esophagitis.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are observed over 12 months to assess the presence of Barrett's esophagitis.

Trial Site Locations

Total: 3 locations

1

ACUTE Center for Eating Disorders and Severe Malnutrition

Denver, Colorado, United States, 80204

Actively Recruiting

2

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Actively Recruiting

3

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Actively Recruiting

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Research Team

M

Marina J Foster, BA

A

Allison Nitsch, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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