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

N/AUnknownNCT05191810

Medical University of Warsaw110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Constipation - Functional

Interventions

Educational informationBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: last week of intervention

Secondary Outcomes

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

Time frame: 8 weeks

Frequency (number per week) of bowel movements during the fourth and last weeks of intervention

One of the Rome IV constipation criteria

Time frame: 8 weeks

Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention

One of the Rome IV constipation criteria

Time frame: 8 weeks

Painful bowel movements (number per week) during the fourth and last weeks of intervention

One of the Rome IV constipation criteria

Time frame: 8 weeks

Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention

Symptoms related to constipation

Time frame: 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).

Central Contacts

Piotr Dziechciarz, MD PhD

CONTACT

+48223179539 piotr.dziechciarz@wum.edu.pl

Data from ClinicalTrials.gov

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