Dietary Fiber Mixture in Constipated Pediatric Patients

NCT01333787 | Completed Phase 4 DMC

• 1 other identifier: FiberCCF - EPM2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

dietary fiber; clinical trial; constipation; children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Frequent daily evacuations, format and consistency of the feces, total and segmental transit time

  4 weeks

Study Arms (2)

Dietary Fiber Mixture

ACTIVE COMPARATOR

The dietary fiber mixture was composed of six different types of fibers. It was used for treatment of chronic constipation in children.

Dietary Supplement: Dietary Fiber Mixture

Maltodextrine

PLACEBO COMPARATOR

Blinded control group

Dietary Supplement: Dietary Fiber Mixture

Interventions

Dietary Fiber Mixture DIETARY_SUPPLEMENT

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.

Also known as: Stimulance

Dietary Fiber Mixture; Maltodextrine

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Mauro Batista de Morais: collaborator
• Soraia Tahan: collaborator
• Mauro Sérgio Toporovski: collaborator
• Clarice Blaj Neufeld: collaborator
• Thabata Koester Weber: collaborator

Study Sites (1)

UNIFESP - Pediatric Gastroenterology Ambulatory

São Paulo, São Paulo, 04039-031, Brazil

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 12, 2011
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2010
• Last Updated: April 12, 2011

Record last verified: 2010-12

Locations

BR (1)