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IRCT20120415009475N5 IRCT 2018-10-10 Shahid Beheshti University of Medical Sciences Effects of Saccharomyces Boulardii capsules in pediatric Inflammatory bowel disease Evaluation of the effects of lyophilized Saccharomyces Boulardii capsules on quality of life and clinical outcomes in children with inflammatory bowel disease (IBD) 2018-03-06 anticipated 60 Complete https://irct.ir/trial/32179 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: the randomization has been performed using the permuted block randomization table, Blinding description: The drug and placebo will be in coded same packages; a designated person will provide the codes from permuted block randomization via phone. The same person will group the data at the end of the trial, and the expert will perform statistical analysis and after results, the pocket that is with the placebo provider would be opened, and the data will be decrypted. The data regarding harm and benefits of treatment will be provided to the patient and caregiver. 3 Inflammatory bowel disease. Intervention 1: Intervention group: The patients receive two capsules for two months that each capsule contain 250 milligram Saccharomyces Boulardii. Intervention 2: Control group: this group receive two placebo capsule for two months. Yes - There is a plan to make this available What will be shared: The main outcome including questionnaire score will be available. When: Six months after publishing data. To whom: The data will be available per request for people working in academic institutions. Conditions: the data will available for using in systematic review and meta-analysis. Where to obtain: the data will be available by contacting email; mirrahimi@sbmu.ac.ir. How to obtain: The request with the systematic review protocol will be reviewed and answered in two weeks. Comments:
public Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Bahador Mirrahimi
Mofid children's Hospital, Miradmad Junction, Shariaty Ave.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7020 mirrahimi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Children the age of 1-16 Children with IBD 1 year 16 years Both primary and secondary immunodeficiency allergy to drug Treatment - Drugs Treatment - Drugs Intervention group: The patients receive two capsules for two months that each capsule contain 250 milligram Saccharomyces Boulardii Control group: this group receive two placebo capsule for two months. Pain. Timepoint: In this study we checked the effects of Saccharomyces Boulardii capsules in the beginning of the study and two months later. Method of measurement: by interview and completing Visual Analogue Scale by patients. Quality of life. Timepoint: In this study we checked the effects of Saccharomyces Boulardii capsules in the beginning of the study and two months later. Method of measurement: By interview and completing IMPACT III questionnaire. Shahid Beheshti University of Medical Sciences Approved 2017-12-30 Ethics committee of Shahid Beheshti University of Medical Sciences Sharyati Ave.,Mofid hospital Tehran Tehran Iran (Islamic Republic of)