Morphological Markers of Gastroesophageal Reflux Disease (GERD)
A legfontosabb adatok
- Ki végzi
- Baylor College of Medicine
- Hol
- Houston (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Felfüggesztve
- Résztvevők
- 54 fő vett részt
- Kezdés
- 2013. márc.
- Várható befejezés
- 2026. dec.
- A vizsgálat típusa
- Megfigyeléses, 3 csoport
- A vizsgált kezelések
- Sample collection and Questionnaire
- A regiszteradat frissítve
- 2026. augusztus 17.
- Miért állt le
- Study objectives were not met and lack of funding
Ki vehet részt
- Életkor
- 8 év – 18 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Részt vehetnek
A regiszter feltételei, szó szerint
Mind a 12 feltétel megnézéseKevesebb
Ki vehet részt
- Children between the ages of 8-18 years
- Suspected diagnosis of GERD or EoE based on symptom criteria
- Able to tolerate upper endoscopy examination with biopsies
- Children between the ages of 8-18
- Scheduled for EGD for clinical indications
- No history of esophageal disease of esophageal symptoms
- Able to tolerate upper endoscopy examination with biopsies
Ki nem vehet részt
- Previous esophageal or gastric surgery
- History of Barrett's esophagus
- History of congenital defect/malformation of the esophagus
- Diagnosis of Crohn disease
- Symptoms of GERD or EoE (including heartburn, regurgitation, difficulty swallowing, painful swallowing)
Helyszínek itt: Egyesült Államok
- Texas Children's HospitalHouston, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
The purpose of this project is to learn more about a new and promising way to diagnose acid reflux disease using a very high-powered microscope. This special microscope provides much finer detail than typical microscopes previously used for diagnosing reflux, and may help doctors to better identify children with acid reflux.
A vizsgálat 3 csoportja
- Gastroesophageal Reflux Disease (GERD)
History of troublesome symptoms (e.g. heartburn, chest pain, acid regurgitation) secondary to reflux of gastric contents at least three times per week AND, At least one of the following: * Mucosal breaks on endoscopy (at least Grade-A esophagitis based on Los Angeles classification) * Abnormal pH index (pH less than 4 for greater than 6% of study) * Abnormal MII-pH (greater than 73 episodes of total reflux per 24 hours)
Kezelés: Sample collection and Questionnaire
- Eosinophilic Esophagitis (EoE)
* History of troublesome esophageal symptoms (e.g. dysphagia, food impaction, vomiting, upper abdominal or chest pain) * Greater than or equal to 15 eosinophils in at least one high powered field (HPF) from distal OR proximal esophageal biopsy * Lack of histological response to 6-8 weeks of high dose Proton Pump Inhibitor (PPI) OR negative pH probe (pH less than 4 for less than 6% of study). Subjects with greater than 15 eosinophils/HPF and abnormal pH results may have an overlap syndrome and will be excluded from the primary analysis.
Kezelés: Sample collection and Questionnaire
- Control
Patients with no history of troublesome esophageal symptoms or esophageal disease AND normal esophagoscopy (for example, patients undergoing evaluation for chronic abdominal pain, inflammatory bowel disease, celiac disease).
Kezelés: Sample collection and Questionnaire
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Dilation of Intercellular Spaces as Morphological Markers of Gastroesophageal Reflux Disease (GERD)In Children
- A regiszteradat frissítve
- 2026. augusztus 17.