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

Phase 4

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Soy polysaccharide fiber

• Registration Number: NCT01267370
• Lead Sponsor: Federal University of São Paulo

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).

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2002-12
• Status Verified: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2010-12-27
• Study First Submitted QC: 2010-12-27
• Last Update Submitted: 2010-12-27
• Study First Posted: 2010-12-28
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

• The exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Soy polysaccharide fiber	Soy polysaccharide fiber	Dietary fiber for treatment of chronic constipation in children
purified soy extract, with no fiber)	Soy polysaccharide fiber	blinded control group

Primary Outcome Measures

Name	Time	Method
Clinical response	6 weeks	Frequency of stool passage, paiful defecation, stool consistency

Secondary Outcome Measures

Name	Time	Method
total and segmental colonic transit time and fecal weight and moisture	6 weeks	Colonic transit time was evaluated by the technique of Metcalf et al. In brief, a plain abdominal radiograph performed after 24 hours from the last ingestion of 3 sets of 20 distinctive radio-opaque markers taken on 3 consecutive days. In the presence of \> 20% of the markers, a further radiography was taken on the 7th day. The colonic segments were delimitated according to Arhan et al. The patients were instructed to collect the 3-day stools separately from the urine. The collected stools were used to determine the fecal weight and moisture.

Trial Locations

Locations (1)

Division of Pediatric Gastroenterology UNIFESP; 🇧🇷 São Paulo, Brazil