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The efficacy of poloxamer188 oral formulation for the treatment of infants dyschezia

Comparative efficacy of poloxamer188 oral formulation and polyethylene glycol 3350 for the treatment of infants dyschezia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090808002306N11
Enrollment
60
Registered
2026-02-18
Start date
2026-03-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Infants dyschezia.

Interventions

Intervention 1: The cases group will receive (oral extemporaneous pharmacy-made Ploxamer with a dose of 1 mg/kg one time per day) for 2 weeks
the quality of treatment will be assessed at the next visit based on the child's mother's report in terms of the number of bowel movements and the presence or absence of difficulty in defecation. Inte
the quality of treatment was assessed at the next visit based on the child's mother's report in terms of the number of bowel movements and the presence or absence of difficulty in defecation.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 24 Months

Inclusion criteria

Inclusion criteria: All infants (more than 30 days old) with dyschezia and without organic reasons for it, patients also should not have been treated for it in the past week before the intervention

Exclusion criteria

Exclusion criteria: Parents request for exclusion any previous PEG3350 related hypersensitivity any previous Poloxamer 188 related hypersensitivity

Design outcomes

Primary

MeasureTime frame
Defication frequency and difficulty. Timepoint: Before and after the study with a 2 weeks interval. Method of measurement: Observation , counting and Visual analog scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Mohammad Sabzghabaee

Esfahan University of Medical Sciences

sabzghaba@pharm.mui.ac.r+98 31 3669 2288

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026