Functional Constipation
Conditions
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 Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study.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.
Interventions
DRUGMagnesium 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
DRUGMIYAIRI-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
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
This trial is expected to recruit 180 children, but the actual willingness to participate in the trial is 153 children.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 42 |
| 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 | 41 |
| Healthy Children Healthy children without any treatment | 42 |
| Total | 125 |
Baseline characteristics
| Characteristic | Magnesium Oxide and MIYAIRI-BM | Magnesium Oxide | Healthy Children | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 41 Participants | 42 Participants | 125 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.75 years STANDARD_DEVIATION 1.25 | 3.92 years STANDARD_DEVIATION 1.83 | 4.08 years STANDARD_DEVIATION 2.41 | 3.58 years STANDARD_DEVIATION 1.83 |
| Sex: Female, Male Female | 24 Participants | 23 Participants | 17 Participants | 64 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 25 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 51 | 0 / 44 |
| other Total, other adverse events | 0 / 58 | 0 / 51 | 0 / 44 |
| serious Total, serious adverse events | 0 / 58 | 0 / 51 | 0 / 44 |
Outcome results
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.
Time frame: Change from baseline Clostridium butyricum Miyairi expression at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Oxide and MIYAIRI-BM | Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. | 0.00486 number of bacteria per mg of feces | Standard Deviation 0.00696 |
| Magnesium Oxide | Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. | 0.0000148 number of bacteria per mg of feces | Standard Deviation 0.0000266 |
| Healthy Children | Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. | 0.00000189 number of bacteria per mg of feces | Standard Deviation 0.00000341 |