Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial (SOYFIBER)
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Purpose
The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Dietary Supplement: Soy polysaccharide fiber |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial |
- Clinical response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Frequency of stool passage, paiful defecation, stool consistency
- total and segmental colonic transit time and fecal weight and moisture [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 30 |
| Study Start Date: | January 2002 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Soy polysaccharide fiber
Dietary fiber for treatment of chronic constipation in children
|
Dietary Supplement: 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®) Other Names:
|
|
Placebo Comparator: purified soy extract, with no fiber)
blinded control group
|
Dietary Supplement: 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®) Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Brazil | |
| Division of Pediatric Gastroenterology UNIFESP | |
| São Paulo, Brazil, 04039-031 | |
More Information
No publications provided
| Responsible Party: | Mauro Batista de Morais, Universidade Federal de São Paulo |
| ClinicalTrials.gov Identifier: | NCT01267370 History of Changes |
| Other Study ID Numbers: | FiberCCF-EPM1 |
| Study First Received: | December 27, 2010 |
| Last Updated: | December 27, 2010 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of São Paulo:
|
clinical trial dietary fiber constipation children |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013