Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial

NCT ID: NCT01267370

Last Updated: 2010-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2003-10-31

Brief Summary

The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.

Detailed Description

The study was performed out at outpatient clinic of Pediatric Gastroenterology at the Federal University of São Paulo (São Paulo, Brazil), located in the southeastern region of Brazil. It is a public referral hospital for pediatric gastroenterology attendance in the Metropolitan area of the São Paulo and in Brazil. In general, the patients go to consultation after a referral from a primary care center.

Study design and sample size The design was a randomized double-blind trial, placebo-controlled study. Sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. It had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).

Conditions

Constipation

Keywords

clinical trial; dietary fiber; constipation; children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Soy polysaccharide fiber

Dietary fiber for treatment of chronic constipation in children

Group Type: ACTIVE_COMPARATOR

Soy polysaccharide fiber

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.

The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.

Arms: Soy polysaccharide fiber, purified soy extract, with no fiber

Other Names:

Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)

purified soy extract, with no fiber)

blinded control group

Group Type: PLACEBO_COMPARATOR

Soy polysaccharide fiber

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.

The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.

Arms: Soy polysaccharide fiber, purified soy extract, with no fiber

Other Names:

Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)

Interventions

Soy polysaccharide fiber

Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been "cleaned out", they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.

The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.

Arms: Soy polysaccharide fiber, purified soy extract, with no fiber

Other Names:

Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Soy polysaccharide fiber (Pró-fibra®); Purified soy extract, with no fiber (Soyac®)

Eligibility Criteria

Inclusion Criteria

• Patients over two years of age at first consultation and chronic functional constipation were included. Chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Eugênia Farias Almeida Motta

UNKNOWN

Sponsor Role: collaborator

Soraia Tahan

UNKNOWN

Sponsor Role: collaborator

Mauro Batista de Morais

UNKNOWN

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Universidade Federal de São Paulo

Locations

Division of Pediatric Gastroenterology UNIFESP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

FiberCCF-EPM1

Identifier Type: -

Identifier Source: org_study_id