Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01528969
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2012-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Xylitol on Oral Microbiota in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014993', 'term': 'Xylitol'}, {'id': 'D013012', 'term': 'Sorbitol'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eino.honkala@hsc.edu.kw', 'phone': '+965 65638938', 'title': 'Prof. Eino Honkala', 'organization': 'Kuwait University, Faculty of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'during the 1st week after the intervention was concluded.', 'description': 'Subjects were interviewed about the possible side-effects (e.g. diarrhea) after the five-weeks intervention in the connection of the follow-up examinations.', 'eventGroups': [{'id': 'EG000', 'title': 'Xylitol', 'description': 'A half of the subjects (n = 37) were randomly allocated into xylitol group.\n\nSubjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.\n\nNone of the subjects had any adverse effects of the consumption of the chewing gum.', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sorbitol', 'description': 'A half of the subjects (n = 38) were randomly allocated into sorbitol group.\n\nSubjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.\n\nNone of the subjects had any adverse effects of the consumption of the chewing gum.', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'notes': 'Interview after the intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MS Counts of Stimulated Saliva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xylitol', 'description': 'A half of the subjects (n = 37) were randomly allocated into xylitol group.\n\nSubjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.'}, {'id': 'OG001', 'title': 'Sorbitol', 'description': 'A half of the subjects (n = 38) were randomly allocated into sorbitol group.\n\nSubjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.86', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': '5-week follow-up', 'categories': [{'measurements': [{'value': '4.29', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '1.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks', 'description': 'The MS counts were measured at the beginning and in the end of the 5 weeks intervention', 'unitOfMeasure': 'MS counts log CFU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Changes in the Counts of the 14 Other Bacterial Species', 'timeFrame': '5 weeks', 'description': 'The bacterial species were measured from stimulated saliva at the beginning and after the intervention', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xylitol', 'description': 'A half of the subjects (n = 37) were randomly allocated into xylitol group.\n\nSubjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks.'}, {'id': 'FG001', 'title': 'Sorbitol', 'description': 'A half of the subjects (n = 38) were randomly allocated into sorbitol group.\n\nSubjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'absent from the school at baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Altogether 122 10-12-year-old boys, whose parents gave a positive consent, participated in the baseline examinations. The study was conducted at one school in Jabriya, Kuwait.', 'preAssignmentDetails': 'Str mutans was measured from plaque and saliva. Those children who had high mutans counts (n=75) were included into the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xylitol', 'description': 'A half of the subjects (n = 37) were randomly allocated into xylitol group.\n\nSubjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.'}, {'id': 'BG001', 'title': 'Sorbitol', 'description': 'A half of the subjects (n = 38) were randomly allocated into sorbitol group.\n\nSubjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '12'}, {'value': '11.5', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '12'}, {'value': '11.5', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kuwait', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Nationality of subjects', 'classes': [{'title': 'Kuwaiti', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'non-Kuwaiti Arab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2012-01-24', 'resultsFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2012-02-05', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-14', 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MS Counts of Stimulated Saliva', 'timeFrame': '5 weeks', 'description': 'The MS counts were measured at the beginning and in the end of the 5 weeks intervention'}], 'secondaryOutcomes': [{'measure': 'The Changes in the Counts of the 14 Other Bacterial Species', 'timeFrame': '5 weeks', 'description': 'The bacterial species were measured from stimulated saliva at the beginning and after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['oral microbiota', 'mutans streptococci', 'xylitol'], 'conditions': ['Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '17063022', 'type': 'BACKGROUND', 'citation': 'Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. doi: 10.1159/000095650.'}, {'pmid': '8850581', 'type': 'BACKGROUND', 'citation': 'Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.'}]}, 'descriptionModule': {'briefSummary': '1. The present controlled, randomized, doubleblind study aims to answer the following questions:\n\n * How will the "normal flora" be affected by the xylitol consumption?\n * Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?\n * The association of the test results will also be compared with the caries status at the baseline.\n2. About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.\n3. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.\n4. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.', 'detailedDescription': 'Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.\n\nThe present controlled, randomized, doubleblind study aims to answer the following questions:\n\n1. How will the "normal flora" be affected by the xylitol consumption?\n2. Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?\n3. The association of the test results will also be compared with the caries status at the baseline.\n\nAfter collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).\n\nSorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* high SM count\n\nExclusion Criteria:\n\n* low SM count,\n* ongoing medication'}, 'identificationModule': {'nctId': 'NCT01528969', 'briefTitle': 'Effect of Xylitol on Oral Microbiota in Children', 'organization': {'class': 'OTHER', 'fullName': 'Kuwait University'}, 'officialTitle': 'The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts', 'orgStudyIdInfo': {'id': 'DD02/10'}, 'secondaryIdInfos': [{'id': 'KU-DD02/10', 'type': 'OTHER_GRANT', 'domain': 'Kuwait University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylitol', 'description': 'A half of the subjects will be randomly allocated into xylitol group.', 'interventionNames': ['Dietary Supplement: xylitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sorbitol', 'description': 'About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day', 'interventionNames': ['Dietary Supplement: sorbitol']}], 'interventions': [{'name': 'xylitol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Xylitol chewing gum', 'Sorbitol chewing gum'], 'description': 'Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.', 'armGroupLabels': ['Xylitol']}, {'name': 'sorbitol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Sorbitol chewing gum'], 'description': 'Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.', 'armGroupLabels': ['Sorbitol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Faculty of Dentistry, Kuwait University', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'overallOfficials': [{'name': 'Eino Honkala, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Kuwait University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuwait University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eino Honkala', 'investigatorAffiliation': 'Kuwait University'}}}}