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IRCT20220413054526N1 IRCT 2022-06-02 Tehran University of Medical Sciences Evaluation of the probiotic effect of Lactobacillus ruteri in the intestinal preparation regimen of children undergoing colonoscopy Evaluation of the probiotic effect of Lactobacillus ruteri in the intestinal preparation regimen of children undergoing colonoscopy 2022-06-22 anticipated 80 Complete https://irct.ir/trial/63706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation will be used as Stratified Randomization using the Permuted block randomization method with quadruple and double blocks. According to the sample size of80 that has been determined, the quadruple and double blocks will be produced using the online site (www.sealedenvelope.com).In the Stratified Randomization method, age and BMI will be used as layers, Blinding description: The study is double-blind. Participants will be divided into 2 groups receiving Lactobacillus ruteri probiotic with Pedrolax powder and Bisacodyl and the placebo receiving group with Pedrolax powder and Bisacodyl. Due to the double-blindness of the study, before starting the study, sets of cans containing probiotic supplementation will be prepared by someone other than the researcher, and the placebo will be similar in appearance to probiotic supplementation, so that the researcher does not know the type of treatment received by each group. In addition, the researcher in the evaluation phase of the desired outcomes from the allocation of participants in each of the groups (intervention and control group) until after the end of the intervention period will be uninformed. 3 Eosinophilic gastritis or gastroenteritis. Intervention 1: Intervention group: Ten days before the colonoscopy, Pediatrics will be on the Lactobacillus ruteri probiotic diet, and 48 hours before the colonoscopy, they will be on the bisacodyl and polyethylene glycol diet. The protocol for using the probiotic Lactobacillus ruteri is to dissolve the rotroflora sachet 10 sachets daily for children 2 to 5 years old and two sachets daily for children 5 to 14 years old in water, yogurt or lukewarm food 10 days before colonoscopy. It is also recommended that all patients use a well-drained fluid diet 48 hours before colonoscopy. Intervention 2: Control group: Pediatrics will receive a placebo supplement ten days before the colonoscopy and will also be on a bisacodyl and polyethylene glycol diet 48 hours before the colonoscopy. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Parisa Rahmani
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 0024 cmcpr@tums.ac.ir Tehran University of Medical Sciences scientific Parisa Rahmani
Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6693 0024 cmcpr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Children in the age range of 2 to 14 years. No history of any allergic reactions. No inflammatory bowel disease including Crohn's disease and ulcerative colitis, no intestinal obstruction, no megacolon toxin and no severe constipation. 2 years 14 years Both Having any acute illness The occurrence of any accident that affects a person's health. Acceptance rate less than 80% Changes in medications taken during the study period Exclusion based on personal preference of participants or their parents K52.81 Eosinophilic gastritis or gastroenteritis Treatment - Other Placebo Intervention group: Ten days before the colonoscopy, Pediatrics will be on the Lactobacillus ruteri probiotic diet, and 48 hours before the colonoscopy, they will be on the bisacodyl and polyethylene glycol diet. The protocol for using the probiotic Lactobacillus ruteri is to dissolve the rotroflora sachet 10 sachets daily for children 2 to 5 years old and two sachets daily for children 5 to 14 years old in water, yogurt or lukewarm food 10 days before colonoscopy. It is also recommended that all patients use a well-drained fluid diet 48 hours before colonoscopy. Control group: Pediatrics will receive a placebo supplement ten days before the colonoscopy and will also be on a bisacodyl and polyethylene glycol diet 48 hours before the colonoscopy. Boston Bowel Preparation Scale. Timepoint: End of the study. Method of measurement: Questionnaire. Duration of colonoscopy. Timepoint: End of the study. Method of measurement: Questionnaire. Age. Timepoint: End of study. Method of measurement: Questionnaire. Sex. Timepoint: End of study. Method of measurement: Questionnaire. Weight. Timepoint: Beginning and end of the study. Method of measurement: scale. Tehran University of Medical Sciences Approved 2022-05-19 Research Ethics Committees of Children’s Medical Center- Tehran University of Medical Sciences Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)