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IRCT138811193309N1 IRCT 2010-04-20 Tehran University of Medical Sciences The Role of Synbiotic in the Treatment of Childhood Constipation The Role of Synbiotic in the Treatment of Childhood Constipation 2009-03-21 anticipated 30 Complete https://irct.ir/trial/3380 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Other diseases of intestines. Intervention 1: 1.5 ml/kg/day oral liquid paraffin plus placebo (placebo sachet with the same shape and color to synbiotic). Intervention 2: 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic) and placebo (with the same shape and color to paraffin oil). Intervention 3: 1.5 ml/kg/day oral liquid paraffin and 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic).
public Dr. Manijh Khalili
Department of Gastroenterology, Children's Medical Center Hospital, Tehran University of Medical Science
Tehran تهران Iran (Islamic Republic of) +98 21 2213 0265 dr_khalili2000@yahoo.com Tehran University of Medical Sciences scientific Dr. Ahmad Khodadad
Department of Gastroenterology, Children's Medical Center Hospital, Tehran University of Medical Science مرکز طبی کودکان
Tehran Iran (Islamic Republic of) +98 21 6692 4545 khodadadmd@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age 4-12 years, diagnosis based on Room III criteria as two months of at least 2 or more of the following: less than 2 defecation in the toilet per week, more than 1 episode of fecal incontinence per week, history of retentive posturing or excessive volitional stool retention, history of painful or hard bowel movements, presence of a large fecal mass in the rectum, history of large diameter stools that may obstruct the toilet. Exclusion criteria: presence of organic causes for constipation; including Hirschsprung’s disease, spina bifida occulta, hypothyroidism, cystic fibrosis, neurologic abnormalities and intestinal pseudo-obstruction 4 years 12 years Both K59.0 Constipation Treatment - Drugs Treatment - Drugs Treatment - Drugs 1.5 ml/kg/day oral liquid paraffin plus placebo (placebo sachet with the same shape and color to synbiotic) 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic) and placebo (with the same shape and color to paraffin oil) 1.5 ml/kg/day oral liquid paraffin and 1 sachet of synbiotic per day (Restore 1 billion CFU/1 sachet, Made by Protexin Co. in UK, synbiotic combination were probiotic strains containing L. casei, L. rhamnosus, S. thermophilus, B. breve, L. acidophilus, B. infantis and Fructooligosaccharide as prebiotic) Frequency of bowel movements per week. Timepoint: 4 weeks. Method of measurement: Questionnarie. Stool consistency. Timepoint: 4 Weeks. Method of measurement: Questionnarie. Frequency of stool incontinence per week. Timepoint: 4 Weeks. Method of measurement: questionnarie. Abdominal pain. Timepoint: 4 weeks. Method of measurement: questionnarie. Painful defecation. Timepoint: 4 weeks. Method of measurement: Questionnarie. Success treatment. Timepoint: 4 weeks. Method of measurement: Success treatment defined as ≥ 3 Bowel Movements per week,≤ 2 incontinence per month and no abdominal pain. Adverse effects. Timepoint: 4 weeks. Method of measurement: Questionnarie. Tehran University of Medical Sciences Approved 2010-02-08 Research Deputy of Tehran University of Medical Sciences Tehran University of Medical Science, 16 Azar St. Tehran Iran (Islamic Republic of)