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IRCT201207311579N1 IRCT 2012-09-11 Vice chancellor for research, Islamic Azad University, Najafabad Branch Efficacy of Probiotic in the Treatment of Childhood Functional Constipation Evaluating The Effects of Lactobacillus Sporogenes in Combination with Mineral Oil Compared with Mineral Oil Alone on Symptoms of Constipation in Children aged 2 to 15 Years with Functional Constipation 2010-01-05 anticipated 60 Complete https://irct.ir/trial/984 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Childhood Functional Constipation. Intervention 1: Controls: Mineral oil (Paraffin 1 ml/kg/d) for 8 weeks. Intervention 2: All children: Toilet training and dietary advices. Intervention 3: Intervention: Synbiotic (Lactol®, Bioplus Life Sciences Pvt. 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) for 8 weeks. The synbiotic used in this study composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol. http://journals.mui.ac.ir/jrms/article/view/8950/3809 Background: Functional constipation is one of the most prevalent childhood gastrointestinal disorders. We evaluated effects of adding a probiotic to mineral oil in the treatment of functional constipation in children.<br /> Materials and Methods: This controlled trial was conducted on 60 children (2 to 14 years old) with functional constipation (Rome III criteria). Children were allocated to receive the synbiotic (Lactol®, composed of Lactobacillus Sporogenes, 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) or the mineral oil alone for two months. Symptoms of constipation including defecation frequency, stool form, strain and pain at defecation, incomplete evacuation and soiling were assessed and compared before and after the intervention. After the treatment period, the two groups were also compared with regards to subjective global improvement.<br /> Results: After the treatment, stool frequency increased in both groups (P < 0.001), with greater increase in synbiotic + mineral oil group (P = 0.001). Frequency of hard/very hard stool and frequency of painful defecation decreased similarly in both groups (P < 0.001). Straining at defecation, incomplete evacuation, and soiling decreased in both groups (P < 0.001), but more decrease was seen in the synbiotic + mineral oil group (P < 0.05). Finally, there was a better global improvement in the synbiotic + mineral oil group (P < 0.05). No severe side effects were observed in any group.<br /> Conclusion: Adding the synbiotic Lactol® (containing Lactobacillus Sporogenes) to mineral oil can increase the improvement in children constipation symptoms without specific side effects.
public Dr. Ali Gholamrezaei
Hezar Jarib Street
Isfahan Iran (Islamic Republic of) +98 31 1669 8675 ali.gholamrezaei.63@gmail.com Medical Students' Research Center, Isfahan University of Medical Sciences scientific Dr. Hossein Saneian
Department of Pediatrics, Alzahra Hospital, Soffeh Ave.
Isfahan Iran (Islamic Republic of) +98 31 1668 5555 saneian@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria: 1- Children 2 to 15 years of age, 2- Having functional constipation based on the Rome III criteria, 3- Parents' Consent for Participation. Exclusion Criteria: 1- Those with immunocompromised condition or other severe diseases, 2- Those receiving antibiotic in the previous four weeks, 3- Experiencing severe side effects, gastroenteritis, or receiving antibiotic for any reason during the study period. 2 years 15 years Both K59.0 Constipation Treatment - Drugs Behavior Treatment - Drugs Controls: Mineral oil (Paraffin 1 ml/kg/d) for 8 weeks All children: Toilet training and dietary advices Intervention: Synbiotic (Lactol®, Bioplus Life Sciences Pvt. 1 Tab/20kg/d) plus mineral oil (Paraffin 1 ml/kg/d) for 8 weeks. The synbiotic used in this study composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol. Symptoms of constipation. Timepoint: Before and 2 months after treatment. Method of measurement: Rome III questionnaire. Global improvement. Timepoint: Two months after treatment. Method of measurement: Questionnaire. Vice chancellor for research, Islamic Azad University, Najafabad Branch Approved 2010-01-05 The Ethics Committee of Islamic Azad University, Najafabad Branch University Ave. Najafabad Iran (Islamic Republic of)