Constipation - Functional
Conditions
Keywords
fluid intake, functional constipation, children, PEG, macrogol, educational intervention
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.
Interventions
BEHAVIORALEducational information
Educational information about non-pharmacological supporting treatment of functional constipation, involving recommendation of adequate for age fluid intake
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Stomachache and bloating (number of episodes per week) during the fourth and last weeks of intervention | 8 weeks | Symptoms related to constipation |
| Painful bowel movements (number per week) during the fourth and last weeks of intervention | 8 weeks | One of 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 |
| 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). |
Contacts
Primary ContactPiotr Dziechciarz, MD PhD
Outcome results
None listed