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Development, Validation and Evaluation of an Adult and Pediatric Eosinophilic Esophagitis Activity Index (EEsAI Trial)

N/A
Waitlist Available
Led By Alain Schoepfer, MD, PD+MER1
Research Sponsored by University Hospital Inselspital, Berne
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease of the esophagus affecting children and adults. The most frequent symptoms are swallowing difficulties and thoracic pain. The disease has first been described in the 1980s and is found with rapidly increasing frequency mainly in industrialized countries. The factors that lead to EoE are until now incompletely understood, of importance, the disease is found more frequently in men and patients suffering from allergic diseases (e.g., Asthma). So far there exists no activity index to define the severity of EoE; such an index is urgently needed for future clinical trials to determine the efficacy of current and future therapies. The investigators' 3-year project, carried out in cooperation with international EoE experts, aims at the development of an activity index for adult and pediatric EoE patients that will be used in future clinical trials as well as observational studies.

Eligible Conditions
  • Muscle Tension Dysphagia
  • Functional Esophageal Disorders
  • Chikungunya Virus
  • Swallowing Disorders
  • Esophageal Diseases
  • Eosinophilia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
cohorts 2 (evaluation phase): 200 children with Eosinophilic Esophagitis, 200 adults with Eosinophilic Esophagitis
Group II: 1Experimental Treatment1 Intervention
cohorts 1 (item weighting phase): 100 children with Eosinophilic Esophagitis, 150 adults with Eosinophilic Esophagitis

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,652 Previous Clinical Trials
960,865 Total Patients Enrolled
Kantonsspital OltenOTHER
12 Previous Clinical Trials
4,052 Total Patients Enrolled
University of CincinnatiOTHER
439 Previous Clinical Trials
638,098 Total Patients Enrolled
Luzerner KantonsspitalOTHER
88 Previous Clinical Trials
325,282 Total Patients Enrolled
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,474 Total Patients Enrolled
1 Trials studying Muscle Tension Dysphagia
22 Patients Enrolled for Muscle Tension Dysphagia
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,919,330 Total Patients Enrolled
Indiana University School of MedicineOTHER
192 Previous Clinical Trials
178,757 Total Patients Enrolled
Philadelphia UniversityOTHER
University Hospital Inselspital, BerneLead Sponsor
721 Previous Clinical Trials
2,248,167 Total Patients Enrolled
Insel Gruppe AG, University Hospital BernLead Sponsor
813 Previous Clinical Trials
2,346,136 Total Patients Enrolled
~43 spots leftby Jan 2026