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

Evaluation of effect of motilium as adjuvant therapy with polyethylene glycol in treatment of chronic functional constipation in children in comparison to placebo

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204259101N2
Enrollment
105
Registered
2012-06-13
Start date
2011-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic constipation. Constipation

Interventions

Intervention 1: Treatment with polyethylene glycol 0.6 gram/Kg/day two times a day for 6 months and motilium syrup 0.15 mg/Kg/dose three times a day for 3 months (1 mL=1 mg Syrup). Intervention 2: Tre
Treatment - Drugs
Placebo
Treatment with polyethylene glycol 0.6 gram/Kg/day two times a day for 6 months and motilium syrup 0.15 mg/Kg/dose three times a day for 3 months (1 mL=1 mg Syrup)
Treatment with polyethylene glycol 0.6 gram/Kg/day two times a day for 6 months and placebo syrup 0.15 mL/Kg/dose three times a day for 3 months

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohsen Dehghani

Shiraz University of Medical Sciences

dehghanism@sums.ac.ir+98 71 1647 4298

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026