Constipation Clinical Trial
Official title:
Soy Polysaccharide Fiber for the Treatment of Chronic Constipation in Children: a Randomized, Double-blind Trial
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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