Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children

Azienda Policlinico Umberto I96 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Constipation Faecal Impaction

Interventions

Polyethylene glycol with electrolytesDRUG

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.

Polyethylene glycolDEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Efficacy

Stool frequency over the 4 weeks of treatment: daily recording of the number of stool on a patient diary card

Time frame: 4 weeks of observation

Efficacy

Feacal impaction resolution

Time frame: 7 days

Secondary Outcomes

Clinical tolerability

Recording of all Adverse Events (AEs) occurred during the study

Time frame: 4 weeks of observation

Acceptability

Palatability and easy of taking the solution evaluated by a 5-points scale

Time frame: 4 weeks of observation

Compliance

Percentage of patients who took more than 80% of the prescribed dose

Time frame: 4 weeks

Efficacy

Painfull stools, frequency of abdominal pain, frequency of soling episodes, use of stimulant laxatives by collection data on a patient diary card

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.