]>
IRCT20171230038142N14 IRCT 2020-03-11 Esfahan University of Medical Sciences evaluation of efficacy of synbiotics in children with eosinophilic esophagitis evaluation of efficacy of synbiotics in resolution of symptoms , pathologic and endoscopic findings in children with eosinophilic esophagitis 2019-10-23 anticipated 40 Complete https://irct.ir/trial/45056 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to the control and intervention groups using the envelope in which the letters (c) stands for control group and the letter (i) stands for intervention group. Initially, 20 envelopes with the letter c and 20 envelopes with the letter i will be considered and, after being selected by the child or their parent, the child's name will be written on it. 2-3 eosinophilic esophagitis. Intervention 1: Intervention group: They will be treated for at least 8 weeks with omeprazole (Iranian from Abidi Pharmacy) at a dose of 1 mg / kg, daily, also under appropriate diet (given nutritional training to parents). And topical steroids will include fluticasone spray and budesonide. Then, 20 patients will receive Cidetabic Synthetic Intervention (from Iranian Bio-Fermentation Pharmaceutical Company) with two daily doses for 8 weeks. Intervention 2: Control group: They will be treated with at least 1 mg / kg once daily for at least 8 weeks of omeprazole (Iranian from Abidi Pharmacy). And topical steroids will include fluticasone spray and budesonide. Then 20 placebo control group will be given two daily doses for 8 weeks. Yes - There is a plan to make this available What will be shared: The information is available to physicians and pediatricians two years after the results are published. When: Two years after the results were published To whom: physicians and pediatricians Conditions: Compare current treatment with other treatment Where to obtain: Request permission from Isfahan Medical School Research Assistant and send an email to gebrahimi676@gmail.com and request. How to obtain: Request permission from Isfahan Medical School Research Assistant and send an email to gebrahimi676@gmail.com and request. Comments:
public Niloufar Zamani
Isfahan University of Medical Sciences, Hazar Jarib Street
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8597 gebrahimi676@gmail.com Esfahan University of Medical Sciences scientific Niloufar Zamani
Isfahan University of Medical Sciences, Hazar Jarib Street
Esfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 8597 gebrahimi676@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient parental consent to participate in the study Eosinophilic esophagitis is diagnosed and confirmed by endoscopy Patients age 6 months to 15 years 6 months 15 years Both Use of other medicines that can improve the disease. K20.0 Eosinophilic esophagitis Treatment - Drugs Diagnosis Intervention group: They will be treated for at least 8 weeks with omeprazole (Iranian from Abidi Pharmacy) at a dose of 1 mg / kg, daily, also under appropriate diet (given nutritional training to parents). And topical steroids will include fluticasone spray and budesonide. Then, 20 patients will receive Cidetabic Synthetic Intervention (from Iranian Bio-Fermentation Pharmaceutical Company) with two daily doses for 8 weeks. Control group: They will be treated with at least 1 mg / kg once daily for at least 8 weeks of omeprazole (Iranian from Abidi Pharmacy). And topical steroids will include fluticasone spray and budesonide. Then 20 placebo control group will be given two daily doses for 8 weeks. Clinical symptoms. Timepoint: Before and eight weeks after intervention. Method of measurement: Examination by a pediatrician. Pathologic findings. Timepoint: Before and eight weeks after intervention. Method of measurement: Gastric biopsy and eosinophil count by microscope. Endoscopic findings. Timepoint: Before and eight weeks after intervention. Method of measurement: Endoscopy in hospital by pediatric gastroenterologist. Esfahan University of Medical Sciences Approved 2019-10-14 Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hazar Jarib Street Esfahan Isfehan Iran (Islamic Republic of)