Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype

NCT ID: NCT06532734

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

EsoGuard

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lucid Diagnostics, Inc.

INDUSTRY

Sponsor Role collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

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Allison Nitsch

Lead Hospitalist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Nitsch, MD

Role: PRINCIPAL_INVESTIGATOR

Denver Health and Hospital Authority

Locations

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ACUTE Center for Eating Disorders and Severe Malnutrition

Denver, Colorado, United States

Site Status RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, United States

Site Status RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marina J Foster, BA

Role: CONTACT

303-602-1913

Allison Nitsch, MD

Role: CONTACT

303-602-5067

Facility Contacts

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Marina J Foster, BA

Role: primary

303-602-1913

Alllison Nitsch, MD

Role: backup

303-602-5067

Marina Foster

Role: primary

3036021913

Marina J Foster, BA

Role: primary

303-602-1913

Alllison Nitsch, MD

Role: backup

303-602-7701

Other Identifiers

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24-0349

Identifier Type: -

Identifier Source: org_study_id

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