Efficacy of Educational Intervention as Supporting Element in the Treatment of Functional Constipation in Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Constipation - Functional
- Sponsor
- Medical University of Warsaw
- Enrollment
- 110
- Primary Endpoint
- Number of Participants who no longer fulfill the Rome IV constipation criteria
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Piotr Dziechciarz, MD
Principal Investigator
Medical University of Warsaw
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of Participants who no longer fulfill the Rome IV constipation criteria
Time Frame: last week of intervention
Success of therapy defined as no longer fulfilling the Rome IV constipation criteria during the last week of intervention.
Secondary Outcomes
- Average daily fluid intake (ml) before 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(8 weeks)
- Frequency of fecal incontinence (number per week) during the fourth and last weeks of intervention(8 weeks)
- Painful bowel movements (number per week) during the fourth and last weeks of intervention(8 weeks)
- Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention(8 weeks)
- Macrogol dose (mg/kg/day) during the fourth and last weeks of intervention(8 weeks)
- Need for rescue laxative treatment during the intervention (number of cases)(8 weeks)
- Time (days) from the start of intervention needed to achieve treatment success.(8 weeks)
- Adverse events during intervention (number and type of reported adverse events)(8 weeks)