Dietary Fiber Mixture in Constipated Pediatric Patients (MIXFIBER)

Federal University of São Paulo

Status and phase

Completed

Phase 4

Conditions

Constipation

Treatments

Dietary Supplement: Dietary Fiber Mixture

Study type

Interventional

Funder types

Other

Identifiers

NCT01333787

FiberCCF - EPM2

Details and patient eligibility

About

The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the treatment of chronic constipation and on the colonic transit time in children.

Full description

In spite of an increase in the consumption of fibers being indicated for the treatment of constipation, few clinical trails have evaluated its efficiency. In the majority of prior studies only the effect of a single type of fiber was evaluated. Each type of fiber presents a particular characteristic, which determines its action mechanism and performance in different parts of the colon. Therefore, theoretically, greater effectiveness could well be observed when different types of fibers are associated into a single product for fiber supplementation.

A randomized, parallel, double-blind, controlled was performed to evaluate the effect of a dietary fiber mixture in constipated pediatric patients.

Children aged between 4 and 12 years were included in the study and the initial diagnosis of functional chronic constipation was made in accordance with the Rome III criteria. The children having attended the Pediatric Gastroenterology Ambulatory of the Federal University of Sao Paulo and the Santa Casa de Misericórdia hospital in Sao Paulo city. All of the children were undergoing constipation maintenance treatment with the use of a laxative in a dosage less than 1.0 ml/Kg for milk of magnesia, mineral oil or lactulose or less than 0.5 g/Kg for polyethylene glycol 3350.

Enrollment

54 patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children aged between 4 and 12 years;
Maintenance treatment using low dose of laxative;
A family with the socio-economic culture that would make it possible to carry out the procedures of the study's protocol.

Exclusion criteria

Children with organic cause constipation such as Hirschsprung disease, cerebral paralysis, anorectal and spinal medulla abnormalities and metabolic illnesses;
The regular use of a fiber supplement during the 4 weeks prior to admission;
The use of medications that would cause constipation;
Absence of a fixed or mobile telephone in order to make contact.