- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01631591
Prevalence of Food Allergies in a Cohort of Adult Patients With Eosinophilic Esophagitis (EE)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Study Population Male and female subjects, ages 18 years and older with findings of > 15 eosinophils per high powered field by endoscopic esophageal biopsy. Patients should also have symptoms consistent with eosinophilic esophagitis including dysphagia, heartburn, epigastric pain, recurrent vomiting, or food impaction. The comparative group will include male and female subjects, ages 18 years and older with a previous diagnosis of gastroesophageal reflux with findings of < 15 eosinophils per high power field by endoscopic esophageal biopsy.
Inclusion Criteria
- Male and female subjects 18 years and older
- Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus
- Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy
Exclusion Criteria
- Male and female subjects less than 18 years of age
- Pregnant female subjects
- Subjects who are receiving systemic steroids and are unable to stop prior to enrollment
- Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment
- Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study
- Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing
- Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit Risks Skin testing with prick methodology has a risk of systemic reaction of less than 0.1% per 40 tests, however, no deaths have been reported with this method of testing. Systemic reactions are readily treated using Injectable epinephrine with oral antihistamines and oral corticosteroids (prednisone). Patch testing has no known associated risk for development of systemic reactions. Phlebotomy is associated with a minimal risk of bleeding, significant local discomfort, and infection from the needle puncture.
Benefits Treatment options for adults with eosinophilic esophagitis are limited. Food allergies are a known contributor to this disorder in children and a better understanding of food allergies in adult subjects may provide additional treatment options.
Adverse Events and Withdrawal Criteria All subjects will be assessed for adverse events at each study visit. If any adverse events are experienced by the subject, the investigator will document the event within the subject's file and promptly report the event to the IRB. The investigators involved with this study will determine if a participant needs to be withdrawn from the study based upon the subject's health and medical history.
Sample Size Sample size estimation is based on the assumption that up to 50% of adults with eosinophilic esophagitis (EE) will have a positive skin test to food and 10% of adults without EE will have a positive skin test to food. With this assumption, a total of 40 subjects are needed, 20 per group, in order to achieve at least 80% power with two sided test at alpha level of 0.05 and beta 0.2.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Florida
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Tampa, Florida, Yhdysvallat, 33613
- University of South Florida
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Male and female subjects 18 years and older
- Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus
- Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy
Exclusion Criteria:
1. Male and female subjects less than 18 years of age 2. Pregnant female subjects 3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment 4. Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment 5. Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study 6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing 7. Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit
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Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Muut
- Aikanäkymät: Muut
Kohortit ja interventiot
Ryhmä/Kohortti |
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eosinophilic esophagitis
PATIENTS WITH A CURRENT DIAGNOSIS OF eosinophilic esophagitis.
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GERD
PATIENTS WITH A DIAGNOSIS WITH GERD.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Prevalence of food allergies in a cohort of adult patients with EE.
Aikaikkuna: Study to close on or around May 2014
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Study to close on or around May 2014
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- eosinophilic esophagitis
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