Status:
UNKNOWN
Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
Lead Sponsor:
Medical University of Warsaw
Conditions:
Constipation - Functional
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether educational intervention (recommendation of adequate fluid intake) is effective as an element supporting the treatment of functional constipation in c...
Detailed Description
Constipation is a common condition in children which affects around 10% of the paediatric population. In 95 % cases it is a functional disorder of the digestive tract, without any organic cause. Recom...
Eligibility Criteria
Inclusion
- Children with functional constipation diagnosed based on Rome IV criteria
Exclusion
- Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
- Children who fulfil the criteria of Irritable Bowel Syndrome
- Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
- Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
- Recurrent or unexplained fevers
- History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
- Concomitant use of drugs that are known to affect gastrointestinal motility
- Established diagnoses of autism spectrum disorders
- Mental retardation
- Children who are exclusively breastfed
- Non-retentive faecal incontinence
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05191810
Start Date
March 7 2022
End Date
December 30 2024
Last Update
March 3 2022
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