Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Children with functional constipation according to the Rome IV criteria will be randomly assigned to receive prunes at dose 3.5 g/kg/d (prune group) or Polyethylene Glycol 4000 (PEG group) at dose 0.5 g/kg/d for 4 weeks. Before treatment children with impaction will receive PEG 4000 at the dose 1.5 g/kg for 3-5 consecutive days. The primary outcome measure will be treatment success, defined as ≥3 BM per week with no fecal soiling during last week of the intervention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Warsaw

Criteria

Inclusion Criteria:

• children with constipation diagnosed with ROME IV criteria

Exclusion Criteria:

• diagnosis of irritable bowel syndrome, mental retardation, endocrine disease (eg, Hyperthyroidism), an organic cause of defecation disorders (eg, Hirshsprung disease, spinal anomalies, anorectal pathology, a history of gastrointestinal surgery), functional nonretentive fecal incontinence, or intake of medications influencing gastrointestinal motility