Dietary Fiber Mixture in Constipated Pediatric Patients

Constipation Clinical Trial

— MIXFIBER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333787
• Other study ID #: FiberCCF - EPM2
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2011
• Last updated: April 11, 2011
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Dietary Fiber Mixture
During the four weeks the patients received fiber mixtures (intervention) or maltodextrine as the placebo. The fiber mixture was composed of six different types of fibers: 10.5% fructooligosaccharides, 12.5% inulin, 24% Arabic gum, 9% resistant starch, 33% Soya polysaccharide e 12% cellulose. The dose was defined in accordance with the child's body weight: 6.3 grams of fiber supplement, which corresponds to 4.8 g of fiber, or placebo(1 table spoon) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing up to 18 kg; 12.6 grams of fiber supplement, which corresponds to 9.6 g of fiber, or placebo (2 table spoons) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing more than 18 Kg.

Locations

Country	Name	City	State
Brazil	UNIFESP - Pediatric Gastroenterology Ambulatory	Sao Paulo

Sponsors (6)

Lead Sponsor	Collaborator
Federal University of São Paulo	Clarice Blaj Neufeld, Mauro Batista de Morais, Mauro Sérgio Toporovski, Soraia Tahan, Thabata Koester Weber

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response - Therapeutic success	The primary outcome result measurement was the therapeutic success. This therapeutic success was considered when the patient demonstrated daily evacuations or had interposing days of pasty consistency, without pain or difficulty and the absence of fecal incontinence during the 4 weeks of intervention, without the need of using a laxative or rectal enema.	4 weeks	No
Secondary	Frequent daily evacuations, format and consistency of the feces, total and segmental transit time	The format and consistency of the feces was evaluated in accordance with the Bristol Stool Form Scale (stool are rated based on water content of the feces, with 1 meaning hard stools to 7 meaning liquid stools).; The colonic transit time was evaluated during the study's final week by way of the method proposed by Bouchoucha et al. (1992).	4 weeks	No