Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

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

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

Study Overview

• Status: Recruiting
• Conditions: Vomiting; Barrett Esophagus; Esophageal Adenocarcinoma; Eating Disorders; Rumination; Anorexia Nervosa, Binge Eating/Purging Type
• Intervention / Treatment: Device: EsoGuard

Detailed Description

A prospective cohort study to assess the presence of BE in those with purging behaviors from their eating disorders has not been completed. There are multiple case reports describing a younger population not meeting typical screening guidelines whom developed this condition. To better define the presence of Barrett's esophagus (BE) via non-endoscopic testing in an eating disorder cohort with purging (vomiting/rumination) behaviors. Individuals with severe forms of eating disorders with purging and ruminating behaviors not meeting the current screening guidelines for BE will still test positive for BE.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Marina J Foster, BA; Phone Number: 303-602-1913; Email: marina.foster@dhha.org
• Study Contact Backup: Name: Allison Nitsch, MD; Phone Number: 303-602-5067; Email: Allison.nitsch@dhha.org

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health and Hospital Authority
      • Contact: Marina J Foster, BA; Phone Number: 303-602-1913; Email: marina.foster@dhha.org
      • Contact: Alllison Nitsch, MD; Phone Number: 303-602-7701; Email: Allison.nitsch@dhha.org
      • Principal Investigator: Allison Nitsch, MD
    • Denver, Colorado, United States, 80204
      • Recruiting
      • ACUTE Center for Eating Disorders and Severe Malnutrition
      • Contact: Marina J Foster, BA; Phone Number: 303-602-1913; Email: marina.foster@dhha.org
      • Contact: Alllison Nitsch, MD; Phone Number: 303-602-5067; Email: dennis.gibson@dhha.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: Lucid Diagnostics, Inc.
• Investigators: Principal Investigator: Allison Nitsch, MD, Denver Health and Hospital Authority

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Hyperphagia; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Rumination Syndrome; Bulimia; Vomiting; Feeding and Eating Disorders; Anorexia Nervosa; Barrett Esophagus; Adenocarcinoma Of Esophagus
• Other Study ID Numbers: 24-0349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No