Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT03054805
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008277', 'term': 'Magnesium Oxide'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chaohero@yahoo.com', 'phone': '88633281200', 'title': 'Dr. Hsun-Chin Chao', 'phoneExt': '8969', 'organization': 'Chang Gung Memorial Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Magnesium Oxide and MIYAIRI-BM', '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.\n\nMIYAIRI-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.\n\nMagnesium 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\n\nMIYAIRI-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', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Magnesium Oxide', '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.\n\nMagnesium 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', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Children', 'description': 'Healthy children without any treatment', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Magnesium Oxide and MIYAIRI-BM', '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.\n\nMIYAIRI-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.\n\nMagnesium 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\n\nMIYAIRI-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'}, {'id': 'OG001', 'title': 'Magnesium Oxide', '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.\n\nMagnesium 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'}, {'id': 'OG002', 'title': 'Healthy Children', 'description': 'Healthy children without any treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00486', 'spread': '0.00696', 'groupId': 'OG000'}, {'value': '0.0000148', 'spread': '0.0000266', 'groupId': 'OG001'}, {'value': '0.00000189', 'spread': '0.00000341', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline Clostridium butyricum Miyairi expression at 3 months.', 'description': 'The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.', 'unitOfMeasure': 'number of bacteria per mg of feces', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Magnesium Oxide and MIYAIRI-BM', '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.\n\nMIYAIRI-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.\n\nMagnesium 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\n\nMIYAIRI-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'}, {'id': 'FG001', 'title': 'Magnesium Oxide', '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.\n\nMagnesium 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'}, {'id': 'FG002', 'title': 'Healthy Children', 'description': 'Healthy children without any treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This trial is expected to recruit 180 children, but the actual willingness to participate in the trial is 153 children.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Magnesium Oxide and MIYAIRI-BM', '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.\n\nMIYAIRI-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.\n\nMagnesium 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\n\nMIYAIRI-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'}, {'id': 'BG001', 'title': 'Magnesium Oxide', '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.\n\nMagnesium 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'}, {'id': 'BG002', 'title': 'Healthy Children', 'description': 'Healthy children without any treatment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.75', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '3.92', 'spread': '1.83', 'groupId': 'BG001'}, {'value': '4.08', 'spread': '2.41', 'groupId': 'BG002'}, {'value': '3.58', 'spread': '1.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-28', 'studyFirstSubmitDate': '2017-01-17', 'resultsFirstSubmitDate': '2017-07-26', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-28', 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.', 'timeFrame': 'Change from baseline Clostridium butyricum Miyairi expression at 3 months.', 'description': 'The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Functional Constipation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe data of the fecal microflora evaluated in 60 healthy children are used as control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:\n\n1. Two or fewer defecations per week.\n2. At least one episode per week of incontinence after acquiring toileting skills.\n3. History of excessive stool retention.\n4. History of painful or hard bowel movements.\n5. Presence of a large fecal mass in the rectum.\n6. 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.\n\nRome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:\n\n1. Two or fewer defecations in the toilet per week.\n2. At least one episode of fecal incontinence per week.\n3. History of retentive posturing or excessive volitional stool retention.\n4. History of painful or hard bowel movements.\n5. Presence of a large fecal mass in the rectum.\n6. 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\n\nExclusion Criteria:\n\n1. gastroesophageal reflux disease\n2. inflammatory bowel disease\n3. cardiopulmonary diseases\n4. liver disease\n5. renal disease\n6. genetic diseases\n7. endocrinal diseases\n8. received abdominal surgeries'}, 'identificationModule': {'nctId': 'NCT03054805', 'briefTitle': 'The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation', 'orgStudyIdInfo': {'id': '103-0519A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium oxide and MIYAIRI-BM', '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.\n\nMIYAIRI-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.', 'interventionNames': ['Drug: Magnesium Oxide', 'Drug: MIYAIRI-BM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium oxide', '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.', 'interventionNames': ['Drug: Magnesium Oxide']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Children', 'description': 'Healthy Children'}], 'interventions': [{'name': 'Magnesium Oxide', 'type': 'DRUG', 'otherNames': ['MgO'], 'description': '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', 'armGroupLabels': ['Magnesium oxide', 'Magnesium oxide and MIYAIRI-BM']}, {'name': 'MIYAIRI-BM', 'type': 'DRUG', 'otherNames': ['Clostridium Butyricum MIYAIRI'], 'description': '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', 'armGroupLabels': ['Magnesium oxide and MIYAIRI-BM']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}