Functional Constipation Clinical Trial
Official title:
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.
The investigators performed a monocentric, prospective, randomized controlled trial including
120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30
healthy age-matched healthy children as control. The investigators shall evaluate the
children according to the Rome III Diagnostic Criteria for functional constipation.
The 120 enrolled patients are randomized in to two groups: Group A receiving magnesium oxide
and probiotics (MIYAIRI-BM), Group B receiving only magnesium oxide. Each patient is assigned
the evaluation constipation symptoms and detection of microflora (beneficial and harmful
bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. Patients who take less
than 80% of the appropriate dose of medications are withdrawn from the study. All patients
included in the study will be given informed oral consent before entering the study.
The data of the fecal microflora evaluated in 60 healthy children are used as control.
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