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

NCT ID: NCT03054805

Last Updated: 2019-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-06-30

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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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

Conditions

Functional Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magnesium oxide and 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.

Group Type: EXPERIMENTAL

Magnesium Oxide

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Magnesium Oxide

Intervention Type: DRUG

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

Healthy Children

Healthy Children

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

MgO; Clostridium Butyricum MIYAIRI

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

103-0519A3

Identifier Type: -

Identifier Source: org_study_id