Clinical trial NCT01333787: Dietary Fiber Mixture in Constipated Pediatric Patients
Official title: A Controlled, Randomized, Double-blind Trial to Evaluate the Effect of a Dietary Fiber Mixture During Maintenance Treatment and on Colonic Transit Time in Constipated Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Keywords: dietary fiber
clinical trial
constipation
children
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Mauro Batista de Morais
name: Soraia Tahan
name: Mauro Sérgio Toporovski
name: Clarice Blaj Neufeld
name: Thabata Koester Weber
First posted: 2011-04-12
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response - Therapeutic success
timeFrame: 4 weeks
Secondary outcomes:
measure: Frequent daily evacuations, format and consistency of the feces, total and segmental transit time
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: UNIFESP - Pediatric Gastroenterology Ambulatory
Study officials:
References: