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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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium oxide and MIYAIRI-BM | Experimental | 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 | Active Comparator | 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. |
|
| Healthy Children | No Intervention | Healthy Children |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Oxide | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline Clostridium butyricum Miyairi expression at 3 months. |
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Inclusion Criteria:
Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:
Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:
Exclusion Criteria:
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This trial is expected to recruit 180 children, but the actual willingness to participate in the trial is 153 children.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 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 |
| FG001 | 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. 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 |
| FG002 | Healthy Children | Healthy children without any treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | number of bacteria per mg of feces | Change from baseline Clostridium butyricum Miyairi expression at 3 months. |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hsun-Chin Chao | Chang Gung Memorial Hospital | 88633281200 | 8969 | chaohero@yahoo.com |
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| ID | Term |
|---|---|
| D008277 | Magnesium Oxide |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
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|
| MIYAIRI-BM | 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 |
|
|
| BG001 | 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. 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 |
| BG002 | Healthy Children | Healthy children without any treatment |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. 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 |
| OG002 | Healthy Children | Healthy children without any treatment |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | 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. 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 | 0 | 51 | 0 | 51 | 0 | 51 |
| EG002 | Healthy Children | Healthy children without any treatment | 0 | 44 | 0 | 44 | 0 | 44 |
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