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

Azienda Policlinico Umberto I

Status and phase

Completed

Phase 4

Conditions

Faecal Impaction

Constipation

Treatments

Device: Polyethylene glycol

Drug: Polyethylene glycol with electrolytes

Study type

Interventional

Funder types

Other

Identifiers

NCT01592734

PEG-P1

Details and patient eligibility

About

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

Full 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.

Enrollment

96 patients

Sex

All

Ages

2 to 16 years old

Volunteers

No Healthy Volunteers

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