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RecruitingNCT06532734Updated Dec 10, 2025

Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

An observational study in Barrett Esophagus, Anorexia Nervosa, Binge Eating/Purging Type and Rumination, sponsored by Denver Health and Hospital Authority. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Denver Health and Hospital Authority · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Barrett Esophagus
  • Anorexia Nervosa, Binge Eating/Purging Type
  • Rumination
  • Vomiting
  • Eating Disorders
  • Esophageal Adenocarcinoma
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceEsoGuard

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

05

What researchers measure

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

    Time frame: 12 months

06

Study locations

3 of 3 sites recruiting
  • 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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06532734
Lead sponsor
Denver Health and Hospital Authority
Collaborators
Lucid Diagnostics, Inc.
Responsible party
Allison Nitsch (Lead Hospitalist, Denver Health and Hospital Authority) — Principal investigator
First posted
Aug 1, 2024
Start date
Nov 12, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Dec 10, 2025

Study contacts

Marina J Foster, BA
Contact
marina.foster@dhha.org
303-602-1913
Allison Nitsch, MD
Contact
Allison.nitsch@dhha.org
303-602-5067
Allison Nitsch, MD
principal investigator · Denver Health and Hospital Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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