Barrett EsophagusNCT06532734
Barrett's Esophagitis in Anorexia Nervosa Binge/Purge Subtype
An observational study of Barrett Esophagus and Anorexia Nervosa, Binge Eating/Purging Type, run by Denver Health and Hospital Authority at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Barrett Esophagus, Anorexia Nervosa, Binge Eating/Purging Type, Rumination
- What is being tested?
- EsoGuard
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Nov 2024to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
ACUTE Center for Eating Disorders and Severe Malnutrition
Denver, Colorado, 80204
Marina J Foster, BA, 303-602-1913, marina.foster@dhha.org
Alllison Nitsch, MD, 303-602-5067, dennis.gibson@dhha.org
- Recruiting
Denver Health and Hospital Authority
Denver, Colorado, 80204
Marina Foster, 3036021913, marina.foster@dhha.org
- Recruiting
Denver Health and Hospital Authority
Denver, Colorado, 80204
Marina J Foster, BA, 303-602-1913, marina.foster@dhha.org
Alllison Nitsch, MD, 303-602-7701, Allison.nitsch@dhha.org
About this study
Official title: 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
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.
- Conditions
- Barrett Esophagus, Anorexia Nervosa, Binge Eating/Purging Type, Rumination, Vomiting, Eating Disorders, Esophageal Adenocarcinoma
- Being tested
- EsoGuard
- Medical subject headings
- Barrett Esophagus, Anorexia Nervosa, Bulimia, Rumination Syndrome, Vomiting, Feeding and Eating Disorders, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoGuardDevice
device used to collect esophageal cell samples to test for the presence of abnormal cells which may indicate a dx of Barrett's esophagitis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EsoGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start12 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Lucid Diagnostics, Inc.
- Responsible party
- Principal investigator, Allison Nitsch, Denver Health and Hospital Authority
- Investigators
- Allison Nitsch, MD, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532734
- Sponsor's protocol ID
- 24-0349
- Status last verified
- Dec 2025
- First submitted
- 29 Jul 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence of Barrett's Esophagitis in a Cohort of People With Eating Disorders Who Engage in Purging Behaviors: A Pilot Study
- ClinicalTrials.gov ID
- NCT06532734
- Acronym / sponsor ID
- 24-0349
- Conditions
- Barrett Esophagus, Anorexia Nervosa, Binge Eating/Purging Type, Rumination, Vomiting, Eating Disorders, Esophageal Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Lucid Diagnostics, Inc.
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AN-BP | – | Device: EsoGuardindividuals with a dx of AN-BP, with a >5-year history of purging, with a frequency of at least once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsoGuarddevice used to collect esophageal cell samples to test for the presence of abnormal cells which may indicate a dx of Barrett's esophagitis. | Device | AN-BP |
Primary outcome
Number of patients positive for BE
Time frame: 12 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Nitsch, MD principal investigator
Denver Health and Hospital Authority
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus and Anorexia Nervosa, Binge Eating/Purging Type, run by Denver Health and Hospital Authority at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina J Foster, BA (303-602-1913, marina.foster@dhha.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients positive for BE (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.