Comparison of effect of probiotic with polyethylene glycol,with polyethylene glycol alone in the treatment of functional constipation in childre

Phase 2

• Conditions: constipation.; Retention,retained-fecal

• Registration Number: IRCT138812222434N3
• Lead Sponsor: Shiraz University of Medical Sciences, vice chancellor for research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.