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

Not Applicable

Not yet recruiting

• Conditions: Constipation - Functional
• Interventions: Behavioral: Educational information

• Registration Number: NCT05191810
• Lead Sponsor: Medical University of Warsaw

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 children.

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. 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 Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03
• Study Start: 2022-03-07
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants who no longer fulfill the Rome IV constipation criteria	last week of intervention	Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.

Secondary Outcome Measures

Name	Time	Method
Average daily fluid intake (ml) before the beginning of the intervention and during the last week of intervention	8 weeks	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
Frequency (number per week) of bowel movements during the fourth and last weeks of intervention	8 weeks	One of the Rome IV constipation criteria
Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention	8 weeks	One of the Rome IV constipation criteria
Painful bowel movements (number per week) during the fourth and last weeks of intervention	8 weeks	One of the Rome IV constipation criteria
Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention	8 weeks	Symptoms related to constipation
Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention	8 weeks	Macrogol dose needed to achieve treatment success (no longer fulfilling the Rome IV constipation criteria).
Need for rescue laxative treatment during the intervention (number of cases)	8 weeks	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.
Time (days) from the start of intervention needed to achieve treatment success.	8 weeks	Time needed to no longer fulfill the Rome IV constipation criteria
Adverse events during intervention (number and type of reported adverse events)	8 weeks	Any adverse events reported by the patient or caregiver