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IRCT138812222434N3 IRCT 2015-05-10 Shiraz University of Medical Sciences, vice chancellor for research Comparison of effect of probiotic with polyethylene glycol,with polyethylene glycol alone in the treatment of functional constipation in children The comparison between effect polyethylene glycol (PEG) Along with Bacillus coagulans (probiotic) with effect polyethylene glycol (PEG) in treatment of functional constipation in Childrens referred to pediatric gastroenterology clinic of Shiraz University of Medical Sciences 2013-09-23 anticipated 80 Complete https://irct.ir/trial/2151 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 constipation. Intervention 1: PEG solution 40% : 0.5gr/kg/dose TID Cap probiotic: 1.5*109 CFU TID. Intervention 2: PEG solution 40% : 0.5gr/kg/dose TID for 6 week.
public Ali Keshtkari
Pediatric GI ward, Nammazi Hospital, Shiraz, Fars
Shiraz Iran (Islamic Republic of) 00 keshtkari@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Hadi Imanieh
Pediatric GI ward, Department of Pediatric, Nammazi Hospital, Shiraz, Fars
Shiraz Iran (Islamic Republic of) +98 71136474298 imaniehm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:All pediatric patient with constipation that fulfilled Rome III criteria for functional constipation without any treatment;All pediatric patient with constipation that fulfilled Rome III criteria for functional constipation without clinical response to polyethylene glycol (PEG) Exclusion criteria:patients received other drugs for constipation except polyethylene glycol (PEG); The presence of organic cause; Dissatisfaction of parents or Patient 1 month 18 years Both k59.0 Retention,retained-fecal Treatment - Drugs Treatment - Drugs PEG solution 40% : 0.5gr/kg/dose TID Cap probiotic: 1.5*109 CFU TID PEG solution 40% : 0.5gr/kg/dose TID for 6 week Stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires. Stool incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires. Stool consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires. Abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires. Pain on defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recorded through questionnaires. Drug adverse effects and clinical response. Timepoint: 6th week and 12th week. Method of measurement: recoded through questionnaires. Evaluation of Clinical response on stool frequency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires. Evaluation of Clinical response on Fecal incontinence. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires. Evaluation of Clinical response on stool Consistency. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires. Evaluation of clinical response of pain during defecation. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires. Evaluation of Clinical response on abdominal pain. Timepoint: 1th week.4thweek.7thweek and 10th week. Method of measurement: recoded through questionnaires. Shiraz University of Medical Sciences, vice chancellor for research Approved 2013-09-28 Medical Ethics Committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences(central building), Zand Street, Shiraz, Fars Shiraz Iran (Islamic Republic of)