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NCT05216133

Biomarkers of Airway Disease, Barrett's and Underdiagnosed Reflux Noninvasively (BADBURN)

Enrolling by Invitation
Not specifiedAges 37–90Observational
NYU Langone Health
~200 participants
Updated 2026-05-01 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Levels of salivary pepsin
Measured over up to Day 365
+6 more outcomes measured

Conditions

Airway Disease
Barrett Esophagus
Gastroesophageal Reflux Disease

Explore related trials

Airway DiseaseBarrett EsophagusGastroesophageal Reflux Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Anna Nolan, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Erosive esophagitis LA grade C or D (as described on endoscopy), OR
Stricture or Barrett's esophagus on endoscopy, OR
Esophageal acid exposure time \>6% on a pH or pH impedance study
Columnar epithelium lining ≥1 cm of the distal esophagus. AND
Histologic examination of biopsy specimens from that columnar epithelium must reveal intestinal metaplasia characterized with goblet cells.

What this trial measures

  • Levels of salivary pepsinup to Day 365

    Saliva will be analyzed using the Peptest. The value of \>/= 16 ng/mL indicates a positive salivary pepsin.

  • pH Levels from Exhaled Breath Condensate (EBC)up to Day 365

    EBC pH assay will be performed

  • Histamine Concentration from Exhaled Breath Condensate (EBC)up to Day 365

    Histamine concentration will be measured with an enzymatic immunoassay

  • Score on Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) Questionnaireup to Day 365

    PAGI-QOL asks about how some of the gastrointestinal problems one may be experiencing (such as pain, discomfort, or other problems) may have affected one's overall quality of life and well-being in the past 2 weeks. PAGI-QOL consists of 30 questions, each scored from 0 (none of the time) to 5 (all of the time). The total score range is 0-150; the higher the score, the less the quality of life and well-being.

  • Score on Patient Assessment of Upper Gastrointestinal Disorders-Symptoms (PAGI-SYM) Questionnaireup to Day 365

    PAGI-SYM asks about the severity of symptoms one may have related one's gastrointestinal problem. The questionnaire consists of 20 symptoms, and each symptom is scored from 0 (none) to 5 (very severe). The total score range is 0-100; the higher the score, the more severe the symptoms.

  • Score on St. George's Respiratory Questionnaire (SGRQ-C)up to Day 365

    SGRQ-C is designed to assess how one's breathing is troubling a participant and how it affects one's life. The questionnaire consists of 14 questions. The total score range is 0-54; the higher the score, the worse the chest trouble.

  • 36-Item Short Form Survey Instrument (SF-36)up to Day 365

    SF-36 captures mental health, general health perception, emotional, and social role functioning. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.