NCT03054805

The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DRUG	Magnesium Oxide	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
DRUG	MIYAIRI-BM	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

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2016-06-01
• First posted: 2017-02-16
• Last updated: 2019-08-14
• Results posted: 2019-08-14