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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05191810

Collaborator

(none)

110

Enrollment

Arms

33.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional	Behavioral: Educational information	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 7, 2022

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Behavioral: Educational information Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake
No Intervention: Control Group Macrogol (PEG 3350, PEG 4000), standard dosage Standard educational information about non-pharmacological supporting treatment

Arm

Intervention/Treatment

Experimental: 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

Behavioral: Educational information

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

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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