Evaluation of effect of motilium in treatment of chronic functional constipation in childre

Phase 3

Completed

• Conditions: chronic constipation.; Constipation

• Registration Number: IRCT201204259101N2
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Having Rome III criteria for definition of functional constipation. Two or more of the following in a child with a developmental age of at least 4 years with insufficient criteria for diagnosis of inflammatory bowel syndrome: Two or fewer defecations in the toilet per week; At least 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 Criteria fulfilled at least once per week for at least 2 months before diagnosis, and one month of at least two of the following in infants up to 4 years of age: Two or fewer defecations per week; At least one episode/week of incontinence after the acquisition of toileting skills; History of excessive stool retention; History of painful or hard bowel movements ; Presence of a large fecal mass in the rectum; History of large diameter stools. The exclusion criteria: constipation due to any organic causes such as Hirschsprung disease, hypothyroidism, anal stenosis or use of medications that cause constipation.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Constipation. Timepoint: before intervention, one month and three months after intervention, and three months after the end of intervention. Method of measurement: Rome III criteria.