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

Chang Gung Medical Foundation

Status and phase: Completed; Phase 4

Conditions: Functional Constipation

Treatments: Drug: Magnesium Oxide; Drug: MIYAIRI-BM

Study type: Interventional

Funder types: Other

Identifiers

NCT03054805

103-0519A3

Details and patient eligibility

About

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.

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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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

Enrollment: 153 patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 3 patient groups

Magnesium oxide and MIYAIRI-BM

Experimental group

Description:

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.

Treatment:

Drug: Magnesium Oxide

Drug: MIYAIRI-BM

Magnesium oxide

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium Oxide

Healthy Children

No Intervention group

Description:

Healthy Children