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

NCT03639142 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-08-23

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

OTHER

Prunus domestica

Patients will receive prunes at dose 3,5 g/kg/d (max.100mg/day) in three portions a day, for 4 weeks (amount of prescribed prunes will be calibrated with the weight that child ought to have on WHO growth charts at 50th percentile). Prunes should be introduced every day in three meals. Prunes can be chopped or grinded before eating them. They can be eaten alone or child may eat them as a part of bigger meal (which is preferred version). Prunes can be introduced with yogurt, cereals, nuts and seeds as a morning meal.

DRUG

Polyethylene Glycol 4000

Patients will receive PEG at dose 0,5 g/kg/d once daily orally, for 4 weeks.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-09-01
Completion
2020-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639142 on ClinicalTrials.gov