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

Study Overview
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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.

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.

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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Behavioral: Educational information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with functional constipation diagnosed based on Rome IV criteria Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Macrogol (PEG 3350, PEG 4000), standard dosage Educational intervention: Recommendation of adequate for age fluid intake plus standard information about non-pharmacological supporting treatment | Behavioral: Educational information<br>* Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake<br>|
| No Intervention: Control Group<br>Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who no longer fulfill the Rome IV constipation criteria | Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention. | last week of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention | Assessed by a 2-day food and fluid intake diary made by patient and/or caregiver at the beginning of the intervention and during the last week of intervention | 8 weeks | 
| Frequency (number per week) of bowel movements during the fourth and last weeks of intervention | One of the Rome IV constipation criteria | 8 weeks | 
| Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention | One of the Rome IV constipation criteria | 8 weeks | 
| Painful bowel movements (number per week) during the fourth and last weeks of intervention | One of the Rome IV constipation criteria | 8 weeks | 
| Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention | Symptoms related to constipation | 8 weeks | 
| Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention | Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria). | 8 weeks | 
| Need for rescue laxative treatment during the intervention (number of cases) | In case of lack of bowel movements for three consecutive days, the macrogol dose will be augmented to 1-1.5g/kg/day until a bowel movement occurs. | 8 weeks | 
| Time (days) from the start of intervention needed to achieve treatment success. | Time needed to no longer fulfill the Rome IV constipation criteria | 8 weeks | 
| Adverse events during intervention (number and type of reported adverse events) | Any adverse events reported by the patient or caregiver | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid intake, functional constipation, children, PEG, macrogol, educational intervention