Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT02692495
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000089083', 'term': 'Body Odor'}, {'id': 'D006209', 'term': 'Halitosis'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'irene.gabashvili@meboresearch.org', 'phone': '(408) 341-9355', 'title': 'Irene Gabashvili, Scientific Director', 'organization': 'MEBO Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All participants were followed up by email for at least one week after discussing their test results.', 'description': 'Adverse effects were defined as any events, expected or not, that affected participant well being, regardless of whether there was a causal relationship with the diagnostic testing and discussion of the results.\n\nSerious adverse events were defined as those that prevented a participant from performing normal activities and required treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Body Odor', 'description': 'individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Halitosis', 'description': 'individuals self-reporting breath malodors but not body odors', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Test Results Outside the Normal Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Body Odor', 'description': 'individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis'}, {'id': 'OG001', 'title': 'Halitosis', 'description': 'individuals with halitosis, not complaining of body odors'}], 'classes': [{'title': 'Elevated blood ethanol', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Elevated blood methanol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 1-propanol', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-propanol', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-methyl-1-propanol', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-methyl-2-propanol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 1-butanol', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-butanol', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-methyl-1-butanol', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-methyl-2-butanol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2-ethyl-1-butanol', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Elevated 2,3-butylene glycol', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased blood acetate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased blood acetate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased blood propionate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased blood butyrate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Succinate out of range', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Valerate out of range', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Increased gut permeability', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased gut permeability', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'increased blood D-lactate', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'increased urine Indicans', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'four years', 'description': 'The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Discriminative Biomarkers in the Subgroups of Malodor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '"Sour" Group', 'description': 'Self-reported predominant odors included "fishy", "ammonia", sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic "fecal odor"'}, {'id': 'OG001', 'title': '"Sweet" Group', 'description': 'Self-reported odors mostly identified as gas, benzene, "burning","sulfur", "rotten vegetables", "rotten eggs", cheesy/sweaty and sulfury fecal, sewage, "burning", and elusive odors that could not be smelled by the sufferer including "PATM" condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).'}, {'id': 'OG002', 'title': '"Lactic" Subgroup', 'description': '"Garbage" odor identified as one of the most common types of odor (subgroup of the "Sour" cluster)'}], 'classes': [{'title': 'D-lactate', 'categories': [{'measurements': [{'value': '7', 'spread': '5', 'groupId': 'OG000'}, {'value': '29', 'spread': '39', 'groupId': 'OG001'}, {'value': '330', 'spread': '245', 'groupId': 'OG002'}]}]}, {'title': '2- butanol', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Butyrate', 'categories': [{'measurements': [{'value': '5', 'spread': '6', 'groupId': 'OG000'}, {'value': '11', 'spread': '3', 'groupId': 'OG001'}, {'value': '6', 'spread': '6', 'groupId': 'OG002'}]}]}, {'title': '2,3-butylene glycol', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Acetate', 'categories': [{'measurements': [{'value': '60.6', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '68.7', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '55.5', 'spread': '37.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'three years', 'description': 'The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters ("Sour" and "Sweet") shown below along with the "Lactic" subgroup from the "Sour" group.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Test Results Outside the Normal Range in Different Subgroups of Malodor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '"Sour" Group', 'description': 'Self-reported predominant odors included "fishy", "ammonia", sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic "fecal odor"'}, {'id': 'OG001', 'title': '"Sweet" Group', 'description': 'Self-reported odors mostly identified as gas, benzene, "burning","sulfur", "rotten vegetables", "rotten eggs", cheesy/sweaty and sulfury fecal, sewage, "burning", and elusive odors that could not be smelled by the sufferer including "PATM" condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).'}, {'id': 'OG002', 'title': '"Lactic" Subgroup', 'description': '"Garbage" odor identified as one of the most common types of odor'}], 'classes': [{'title': 'Ethanol, blood', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Indicans, urine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'B2 vitamin, blood (EGFR activation)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'D lactate, plasma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Three years', 'description': 'Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '"Sour" Group', 'description': 'Self-reported predominant odors included "fishy", "ammonia", sour acetone (body odor associated with alcoholism), fecal-diarrheal, and generic "fecal odor"'}, {'id': 'OG001', 'title': '"Sweet" Group', 'description': 'Self-reported odors mostly identified as gas, benzene, "burning","sulfur", "rotten vegetables", "rotten eggs", cheesy/sweaty and sulfury fecal, sewage, "burning", and elusive odors that could not be smelled by the sufferer including "PATM" condition (odors could not be named, but people near the sufferer exhibited increased displeasure, coughing, sneezing, and rubbing their noses).'}, {'id': 'OG002', 'title': '"Lactic" Subgroup', 'description': '"Garbage" odor identified as one of the most common types of odor'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '5', 'groupId': 'OG000'}, {'value': '25', 'spread': '10', 'groupId': 'OG001'}, {'value': '20', 'spread': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Three years', 'description': 'The measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.', 'unitOfMeasure': 'grams per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Body Odor', 'description': 'individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis'}, {'id': 'FG001', 'title': 'Halitosis', 'description': 'individuals with halitosis (bad breath), not complaining of body odors'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Body Odor', 'description': 'individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis'}, {'id': 'BG001', 'title': 'Halitosis', 'description': 'individuals with halitosis, not complaining of body odors'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '37.5', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '32.6', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of condition', 'classes': [{'title': 'Age at onset of symptoms', 'categories': [{'measurements': [{'value': '21', 'spread': '9', 'groupId': 'BG000'}, {'value': '29', 'spread': '9', 'groupId': 'BG001'}, {'value': '23', 'spread': '9', 'groupId': 'BG002'}]}]}, {'title': 'Duration of symptoms', 'categories': [{'measurements': [{'value': '9', 'spread': '6', 'groupId': 'BG000'}, {'value': '9', 'spread': '5', 'groupId': 'BG001'}, {'value': '9', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-02-16', 'resultsFirstSubmitDate': '2016-03-08', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-03', 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Test Results Outside the Normal Range', 'timeFrame': 'four years', 'description': 'The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.'}], 'secondaryOutcomes': [{'measure': 'Discriminative Biomarkers in the Subgroups of Malodor', 'timeFrame': 'three years', 'description': 'The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters ("Sour" and "Sweet") shown below along with the "Lactic" subgroup from the "Sour" group.'}, {'measure': 'Number of Test Results Outside the Normal Range in Different Subgroups of Malodor', 'timeFrame': 'Three years', 'description': 'Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group'}, {'measure': 'Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor', 'timeFrame': 'Three years', 'description': 'The measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['body odor', 'halitosis', 'dysbiosis', 'leaky gut', 'microbiome', 'PATM', 'breath odor'], 'conditions': ['Nutritional and Metabolic Diseases']}, 'referencesModule': {'availIpds': [{'id': '10.17632/8bk6h6bmkr.1', 'url': 'https://data.mendeley.com/datasets/8bk6h6bmkr/1', 'type': 'Individual Participant Data Set'}, {'url': 'http://www.aurametrix.com/nct02692495', 'type': 'Clinical Study Report'}, {'id': '10.1101/139014', 'url': 'http://biorxiv.org/content/early/2017/05/19/139014', 'type': 'Preprint', 'comment': 'Study results'}], 'references': [{'pmid': '873124', 'type': 'BACKGROUND', 'citation': 'Chadwick VS, Phillips SF, Hofmann AF. Measurements of intestinal permeability using low molecular weight polyethylene glycols (PEG 400). I. Chemical analysis and biological properties of PEG 400. Gastroenterology. 1977 Aug;73(2):241-6.'}, {'pmid': '7139937', 'type': 'BACKGROUND', 'citation': 'Sivakumaran T, Jenkins RT, Walker WH, Goodacre RL. Simplified measurement of polyethylene glycol 400 in urine. Clin Chem. 1982 Dec;28(12):2452-3. No abstract available.'}, {'type': 'BACKGROUND', 'citation': "Hunnisett A., Howard J., Davies S. Gut fermentation (or the 'Auto-brewery') Syndrome: A new clinical test with initial observations and discussion of clinical and biochemical implications J.Nutr.Med.1:33-8, 1990"}, {'pmid': '19567398', 'type': 'BACKGROUND', 'citation': 'Sheedy JR, Wettenhall RE, Scanlon D, Gooley PR, Lewis DP, McGregor N, Stapleton DI, Butt HL, DE Meirleir KL. Increased d-lactic Acid intestinal bacteria in patients with chronic fatigue syndrome. In Vivo. 2009 Jul-Aug;23(4):621-8.'}, {'pmid': '6616831', 'type': 'BACKGROUND', 'citation': 'Ludvigsen CW, Thurn JR, Pierpont GL, Eckfeldt JH. Kinetic enzymic assay for D(-)-lactate, with use of a centrifugal analyzer. Clin Chem. 1983 Oct;29(10):1823-5.'}, {'pmid': '26429966', 'type': 'BACKGROUND', 'citation': "Jenq RR. How's your microbiota? Let's check your urine. Blood. 2015 Oct 1;126(14):1641-2. doi: 10.1182/blood-2015-08-661504."}, {'pmid': '17990113', 'type': 'BACKGROUND', 'citation': 'Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.'}, {'pmid': '16678553', 'type': 'BACKGROUND', 'citation': 'Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.'}, {'pmid': '3827183', 'type': 'BACKGROUND', 'citation': 'Mount JN, Heduan E, Herd C, Jupp R, Kearney E, Marsh A. Adaptation of coenzyme stimulation assays for the nutritional assessment of vitamins B1, B2 and B6 using the Cobas Bio centrifugal analyser. Ann Clin Biochem. 1987 Jan;24 ( Pt 1):41-6. doi: 10.1177/000456328702400106.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed as a retrospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients self-reporting unexpected and uncontrollable episodes of body odor and/or halitosis. The cohort - generally healthy individuals who had underwent multiple diagnostic tests recommended by their physicians and had not been diagnosed with any known medical condition - expressed their interest in trying gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit. Our retrospective analysis will determine if these tests were useful as potential screening tools for metabolic body odor and halitosis.', 'detailedDescription': 'Many yet uncharacterized medical conditions including inborn and acquired errors of metabolism or skewed microbiome could be responsible for unpredictable and uncontrollable episodes of body odor and halitosis. These conditions have dramatic impact on the quality of life and socioeconomic outcomes of sufferers. Yet clinics and specialized malodor centers do not provide tests for diagnosing malodor other than trimethylaminuria (TMAU). Self-reported odor problems are often dismissed if are not organoleptically evaluated by trained odor judges that are not readily available during malodor flare-ups.\n\nThe aim of this study is to analyze effectiveness of existing gastrointestinal and nutritional tests for the assessment and investigation of self-reported malodors.\n\nDiagnostic tests included:\n\n* Gut Permeability Profile. PEG 400 is used as a probe and measured in urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall. Extraction and separation of PEG from urine is done by ion exchange chromatography and capillary GLC.\n* Gut Fermentation Profile. Blood alcohols - ethanol, methanol, butanol, propanol and short chain fatty acids - are measured by gas-liquid chromatography.\n* D-lactate test. D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate\n* The urine indicans (Obermeyer) test. Detection of indican in the urine depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer\n* Breath test for small intestinal dysbiosis. Breath hydrogen and methane are measured by gas-liquid chromatography. The patient is given 10 gm of lactulose in 200 ml of water and alveolar air samples are collected every 20 minutes for 3 hours\n* Functional B vitamins profile, by measuring the activation of a red cell enzyme that is dependent upon an adequate concentration of a particular vitamin for full activity. The assay relies on normal metabolism of the vitamin to its native form and the presence of other non-vitamin cofactors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals reporting idiopathic malodor production', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* idiopathic malodor experienced over a period of several months or years\n* willing and able to complete the study\n* good general health\n\nExclusion Criteria:\n\n* elect not to participate in the study'}, 'identificationModule': {'nctId': 'NCT02692495', 'briefTitle': 'Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis', 'organization': {'class': 'OTHER', 'fullName': 'Mebo Research, Inc.'}, 'officialTitle': 'Evaluation of Gastrointestinal and Nutritional Diagnostic Tests as Potential Screening Tools for Metabolic Body Odor and Halitosis', 'orgStudyIdInfo': {'id': '200904010001MEBO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Body odor', 'description': 'individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis'}, {'label': 'Halitosis', 'description': 'individuals with extra-oral halitosis, not complaining of body odors'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W10 5LE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'MeBO Research LTD', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Irene Gabashvili, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MeBO Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'de-identified individual participant data will be made partially available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mebo Research, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}