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| Name | Class |
|---|---|
| Maria Eugênia Farias Almeida Motta | UNKNOWN |
| Soraia Tahan | UNKNOWN |
| Mauro Batista de Morais | UNKNOWN |
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The study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy polysaccharide fiber | Active Comparator | Dietary fiber for treatment of chronic constipation in children |
|
| purified soy extract, with no fiber) | Placebo Comparator | blinded control group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy polysaccharide fiber | 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®) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Frequency of stool passage, paiful defecation, stool consistency | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| total and segmental colonic transit time and fecal weight and moisture | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pediatric Gastroenterology UNIFESP | São Paulo | São Paulo | 04039-031 | Brazil |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 6 weeks |