Treatment of functional constipatio
Phase 2
- Conditions
- Constipation.Other functional intestinal disordes
- Registration Number
- IRCT2015072723363N1
- Lead Sponsor
- Vice-Chancellor for Research Technology Affairs, Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
2 to 10 years old children who refer to Amirkola children's Hospital with functional constipation based on ROME III criteria.
Exclusion criteria: children beyond 2 years and over 10 years; organic constipation; use other drug induced constipation or diarrhea; or history of use pidrolax and probiotic in 1 years later.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The evaluation response to treatment within 8 weeks according ROME III by evaluation of frequency of defecation in week. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation without pain 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Defecation incontinency 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Drug admission in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.;Adverse effect of drugs in two group 8 weeks after treatment. Timepoint: 8 weeks. Method of measurement: Questionnaire that filling with parents.
- Secondary Outcome Measures
Name Time Method Early relapse of constipation according ROME III criteria after off of drug or need to beginning Pidrolax over 4 weeks up to end of drug. Timepoint: 4 weeks after end of treatment. Method of measurement: Questionnaire that filling with parents.