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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Magnesium oxide 250 mg per day for children with weight \< 15 kg, 500 mg per day for weight \<15-30 kg, and 1000 mg per day for weight \> 30 kg
MIYAIRI-BM 1 g (1package) per day for children with weight \< 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight \> 30 kg
Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.
The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.
Time frame: Change from baseline Clostridium butyricum Miyairi expression at 3 months.
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