Constipation, Faecal Impaction
Conditions
Keywords
chronic constipation, faecal impaction, PEG-only laxative
Brief summary
The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation
Detailed description
Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation. Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools. It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.
Interventions
Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks. Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days.
DEVICEPolyethylene glycol
Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children \> 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks. Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days.
Sponsors
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Azienda Policlinico Umberto I
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
Exclusion criteria
* children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities; * Children receiving medication influencing gastrointestinal motility; * Children with suspected gastrointestinal obstruction or stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 4 weeks of observation | Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical tolerability | 4 weeks of observation | Recording of all Adverse Events (AEs) occurred during the study |
| Acceptability | 4 weeks of observation | Palatability and easy of taking the solution evaluated by a 5-points scale |
| Compliance | 4 weeks | Percentage of patients who took more than 80% of the prescribed dose |
| Efficacy | 4 weeks | Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card |
Outcome results
None listed