Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children

Medical University of Warsaw

Status: Not yet enrolling

Conditions: Constipation - Functional

Treatments: Behavioral: Educational information

Study type: Interventional

Funder types: Other

Identifiers

NCT05191810

ZAPWUM11/2021

Details and patient eligibility

About

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 children.

Full 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. Recommendations of lifestyle modifications accompanying pharmacological treatment of constipation are very popular among healthcare providers, although there is limited data concerning non-pharmacological treatment methods of this condition. Adequate for age fluid intake is now recommended for patients with constipation. Further research is needed to form stronger recommendations in the future. 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 children.

Enrollment: 110 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children with functional constipation diagnosed based on Rome IV criteria

Exclusion criteria

1. Children with organic causes of constipation; eg, anorectal malformations, or Hirschsprung's disease
2. Children who fulfil the criteria of Irritable Bowel Syndrome
3. Significant, unstabilised chronic health conditions requiring major drug adjustment during the last 3 months.
4. Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months
5. Recurrent or unexplained fevers
6. History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy, or hernia repairs
7. Concomitant use of drugs that are known to affect gastrointestinal motility
8. Established diagnoses of autism spectrum disorders
9. Mental retardation
10. Children who are exclusively breastfed
11. Non-retentive faecal incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Study Group

Experimental group

Description:

Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment

Treatment:

Behavioral: Educational information

Control Group

No Intervention group

Description:

Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment