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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2024-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Study Group

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

Group Type EXPERIMENTAL

Educational information

Intervention Type BEHAVIORAL

Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational information

Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No