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IRCT20190831044653N4 IRCT 2020-01-30 Bojnourd University of Medical Sciences Evaluating the effects of yogurt containing probiotics in treating gastroesophageal reflux disease Evaluation of the effects of yogurt containing probiotics in treating gastroesophageal reflux disease: a randomized clinical trial 2019-11-01 anticipated 120 Complete https://irct.ir/trial/44029 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients were randomized based on block permutation methods (permuted block randomization) into the three treatment groups (2 groups (probiotic yogurt and regular yogurt) and a control group). Based on the result of randomization by Permuted Block Randomization and R software, patients are allocated to groups sequentially in order of their meeting. The yogurts, both probiotic and simple, will be provided in the same shape single dose containers without any type definer and will be introduced to the drug distributor with unmeaning code. 2-3 Gastroesophageal reflux disease (GERD). Intervention 1: Intervention group: Ordinary yogurt. Intervention 2: Intervention group: Probiotics yogurt. Intervention 3: Control group: Omeprazole. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Seyed Javad Pournaghi
Bojnourd - Imam Hassan Hospital - 6th floor
Bojnourd Iran (Islamic Republic of) 9418655459 +98 58 3221 0510 pournaghij861@yahoo.com Bojnourd University of Medical Sciences scientific Seyed Javad Pournaghi
Bojnourd - Imam Hassan Hospital - 6th floor
Bojnourd Iran (Islamic Republic of) 9418655459 +98 58 3221 0510 pournaghij861@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) The patient be literate or someone helps him/her in filling the questionnaires Patients should be geographically accessible 18 years no limit Both Age less than 18 years Allergy to dairy products Pregnancy History of gastrointestinal malignancy History of gastric and esophageal surgery and small bowel bypass Liver and kidney and heart dysfunction Concomitant use of NSAIDs and aspirin for up to one week before the study Anticancer or antibiotic use during 4 weeks before referral and participation in this study No anti-acid, hydrogen pump inhibitors, H2 receptor inhibitors in two groups of yogurt recipients during the study Receiving bisphosphenate, cortisone, potassium chloride or iron tablets concurrently in the study Patient's compliance be less than 80% (self-reported by patient) K21 Gastro-esophageal reflux disease Treatment - Other Treatment - Other Treatment - Drugs Intervention group: Ordinary yogurt Intervention group: Probiotics yogurt Control group: Omeprazole Effect on the GERD severity. Timepoint: Baseline, one month and tow months later. Method of measurement: The Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (related to typical symptoms). Effect on the severity of GERD atypical symptoms. Timepoint: Baseline, one month and tow months late. Method of measurement: Reflux Symptom Index and Disease Specific Quality of Life Index questionnaires (related to atypical symptoms). Assessment of quality of life. Timepoint: At baseline, one month and tow months later. Method of measurement: questionnaire. Bojnourd University of Medical Sciences Approved 2019-11-16 Ethics Committee of North Khorasan University of Medical Sciences Bojnourd - Behind Imam Ali Hospital - Deputy of Research and Technology bojnourd North Khorasan Iran (Islamic Republic of)