Investigation and comparison of the efficacy and side effects of only nebulized oral Pulmicort and only inhaled budesonide and diet with oral budesonide nebul in patients aged one to 18 years with eosinophilic esophagitis

Comparison of eosinophilia and clinical symptoms improvement in children with eosinophilic esophagitis in three groups: oral budesonide nebulization intervention, inhaled budesonide spry and non-drug diet regimen, and follow-up of local and systemic side effects.

A randomized, double blinded clinical trial study with community-based and pragmatic control group, and parallel groups

After patient’s selection based on inclusion and exclusion criteria, the basic results of endoscopic, histopathological examination, eosinophil count, as well as routine hematological and biochemical tests will be measured. Patients will be randomly divided into three intervention groups of nebulized oral pulmicort, inhaler budesonide and diet without drug. At the beginning of the study and after the end of week 16th, patients in all groups will be referred again to the center for endoscopy by a specialist physician and will be examined histologically and histologically, as well as eosinophil counts and cortisol examination at 8 am o’clock.

Only patients 1 to 18 years of age with eosinophilic esophagitis will be included in the study. Children with a history of systemic disease, adrenal insufficiency, other congenital or genetic defects, and a history of systemic corticosteroid medications will be excluded from the study.

only oral budesonide nebul group only inhaled budesonide spray group mixed food elimination plus oral nebul

The important outcome of the current survey is the effect of nebulized oral pulmicort, inhaler budesonide and diet without drug for improving of eosinophilic esophagitis which is performed by measuring several factors such as eosinophil counts, as well as endoscopic and histopathological examinations.

For this purpose, the random allocation law method was used. In random allocation (based on probability principles) eliminates the link between intervention and potential distortion.Random allocation was used by variable block method.The randomization unit was individual.In this way, a set of 60 cards was prepared, which included three 20-block blocks of three types of cards A, B, and C, which were randomly and randomly removed for each person by the researcher. The collection could not be returned.

Due to the fact that this study did not have a placebo and the drug form used was completely different. Only the data analyst did not know which group the recorded clinical information belonged to.

Documents and information of demographic data, clinical and pathological findings of all patients will be shared, but personal data are will not be shared.

At the end of study and after publication of article

University researchers physicians pharmacologists

Medical researcher can use data after getting admission from all members of this study for further research

They should contact with Dr. Nastaran Amiri

They should initially contact with Dr. Nastaran Amiri to get permission