Functional ConstipationPhase 4NCT03054805
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
A Phase 4 study testing Magnesium Oxide and MIYAIRI-BM in people with Functional Constipation, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Magnesium Oxide and MIYAIRI-BM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:
- Two or fewer defecations per week.
- At least one episode per week of incontinence after acquiring toileting skills.
- History of excessive stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
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- 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:
- Two or fewer defecations in the toilet per week.
- At least one episode of fecal incontinence per week.
- History of retentive posturing or excessive volitional stool retention.
- History of painful or hard bowel movements.
- Presence of a large fecal mass in the rectum.
- 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
Who cannot join
- gastroesophageal reflux disease
- inflammatory bowel disease
- cardiopulmonary diseases
- liver disease
- renal disease
- genetic diseases
- endocrinal diseases
- received abdominal surgeries
About this study
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.
Read the 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
- Being tested
- Magnesium Oxide, MIYAIRI-BM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium OxideDrug
Also called MgO
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-BMDrug
Also called Clostridium Butyricum MIYAIRI
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Magnesium Oxide; Drug: MIYAIRI-BM |
| 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. Receives: Drug: Magnesium Oxide |
| Healthy Children | No intervention | Healthy Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Clostridium butyricum Miyairi expression at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startSep 2014
- Primary completionDec 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054805
- Sponsor's protocol ID
- 103-0519A3
- Status last verified
- Sep 2014
- First submitted
- 17 Jan 2017
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
- ClinicalTrials.gov ID
- NCT03054805
- Acronym / sponsor ID
- 103-0519A3
- Conditions
- Functional Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium oxide and MIYAIRI-BM | Experimental | Drug: Magnesium Oxide, Drug: MIYAIRI-BMMagnesium 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 | Drug: Magnesium OxideMIYAIRI-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 |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:
- Two or fewer defecations per week.
- At least one episode per week of incontinence after acquiring toileting skills.
- History of excessive stool retention.
- History of painful or hard bowel movements.
Key exclusion criteria (8 listed)
- gastroesophageal reflux disease
- inflammatory bowel disease
- cardiopulmonary diseases
- liver disease
- renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium OxideAlso: MgOMagnesium 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 | Drug | Magnesium oxide, Magnesium oxide and MIYAIRI-BM |
| MIYAIRI-BMAlso: Clostridium Butyricum MIYAIRIMIYAIRI-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 | Drug | Magnesium oxide and MIYAIRI-BM |
Primary outcome
Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Oxide and MIYAIRI-BM in people with Functional Constipation, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children. (time frame: Change from baseline Clostridium butyricum Miyairi expression at 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.