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

Phase 4

Completed

• Conditions: Functional Constipation
• Interventions: Drug: Magnesium Oxide; Drug: MIYAIRI-BM

• Registration Number: NCT03054805
• Lead Sponsor: Chang Gung Memorial Hospital

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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Primary Completion: 2014-12
• Study Completion: 2016-06
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Results First Submitted: 2017-07-26
• Results First Submitted QC: 2019-07-28
• Last Update Submitted: 2019-07-28
• Results First Posted: 2019-08-14
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:

1. Two or fewer defecations per week.
2. At least one episode per week of incontinence after acquiring toileting skills.
3. History of excessive stool retention.
4. History of painful or hard bowel movements.
5. Presence of a large fecal mass in the rectum.
6. History of large-diameter stools that may obstruct the toilet. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month.

Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:

1. Two or fewer defecations in the toilet per week.
2. At least one episode of fecal incontinence per week.
3. History of retentive posturing or excessive volitional stool retention.
4. History of painful or hard bowel movements.
5. Presence of a large fecal mass in the rectum.
6. History of large diameter stools that may obstruct the toilet. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week

Exclusion Criteria

1. gastroesophageal reflux disease
2. inflammatory bowel disease
3. cardiopulmonary diseases
4. liver disease
5. renal disease
6. genetic diseases
7. endocrinal diseases
8. received abdominal surgeries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium oxide and MIYAIRI-BM	Magnesium Oxide	Magnesium oxide 125 mg twice per day for children with weight \< 15 kg, 250 mg twice per day for weight \<15-30 kg, and 500 mg twice per day for weight \> 30 kg for 12 weeks. MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight \< 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight \> 30 kg for 12 weeks.
Magnesium oxide and MIYAIRI-BM	MIYAIRI-BM	Magnesium oxide 125 mg twice per day for children with weight \< 15 kg, 250 mg twice per day for weight \<15-30 kg, and 500 mg twice per day for weight \> 30 kg for 12 weeks. MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight \< 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight \> 30 kg for 12 weeks.
Magnesium oxide	Magnesium Oxide	MIYAIRI-BM 1 package (1g) divided as 0.5 g twice per day for children with weight \< 15 kg, 2 packages divided as 1 g twice per day for weight 15-30 kg, and 3 packages divided as 1.5 g twice per day for weight \> 30 kg for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.	Change from baseline Clostridium butyricum Miyairi expression at 3 months.	The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.