Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-25 @ 4:20 PM
Study NCT ID:
NCT04114357
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2019-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'heismail@iu.edu', 'phone': '317-278-8326', 'title': 'Heba M Ismail', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'description': 'CTCAE was used for adverse and serious adverse event reporting. Data on AEs was collected at the time of each scheduled visit in addition to in between visit during phone communications.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'This arm will consume the supplement daily for 4 weeks.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'This arm will not receive the supplement for 4 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dental Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'bilateral halux infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'yeast infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'rash at sensor insertion site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'low vitamin D', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'sweating during blood draw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'CGM fell off', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Gut Microbiome Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet and not receive the supplement for 4 weeks.'}], 'classes': [{'title': 'Baseline Bifidobacterium Longum', 'categories': [{'measurements': [{'value': '818.5', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '1280'}, {'value': '229', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '609'}]}]}, {'title': 'Bifidobacteria Longum (after 4 weeks)', 'categories': [{'measurements': [{'value': '1610', 'groupId': 'OG000', 'lowerLimit': '382', 'upperLimit': '1819.5'}, {'value': '177', 'groupId': 'OG001', 'lowerLimit': '75.5', 'upperLimit': '924.5'}]}]}, {'title': 'Baseline Parabacteroides distasonis', 'categories': [{'measurements': [{'value': '4964', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9782'}, {'value': '2632', 'groupId': 'OG001', 'lowerLimit': '1407', 'upperLimit': '5179.5'}]}]}, {'title': 'Parabacteroides distasonis (after 4 weeks)', 'categories': [{'measurements': [{'value': '561', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '3556'}, {'value': '561', 'groupId': 'OG001', 'lowerLimit': '136', 'upperLimit': '2986'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile.\n\nThis measure was assesed using the absolute abundance of certain bacterial species of interest.\n\nThe changes will be compared before and after each 4 week time period.', 'unitOfMeasure': 'species count', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in the Short Chain Fatty Acid Levels in the Gut.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks while following the control diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will follow only the control diet without the supplement for 4 weeks.'}], 'classes': [{'title': 'Butyrate', 'categories': [{'measurements': [{'value': '23', 'spread': '6', 'groupId': 'OG000'}, {'value': '19', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Propionate', 'categories': [{'measurements': [{'value': '16', 'spread': '9', 'groupId': 'OG000'}, {'value': '16', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'acetate', 'categories': [{'measurements': [{'value': '60', 'spread': '23', 'groupId': 'OG000'}, {'value': '56', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'Measurement of Short Chain Fatty Acid Levels in the Stools.', 'unitOfMeasure': 'mmol / kg fecal material', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Average Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet and will not receive the supplement for 4 weeks.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '256', 'spread': '19', 'groupId': 'OG000'}, {'value': '228', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': '4 weeks after', 'categories': [{'measurements': [{'value': '232', 'spread': '31', 'groupId': 'OG000'}, {'value': '217', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-peptide Levels (Changes in Beta Cell Health).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet for 4 weeks.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'after 4 weeks', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare β-cell measures pre/post intervention with HAMS-AB and between the intervention and control groups. We will assess β-cell function using mixed meal tolerance-derived C-peptide measurements ( a measure of β-cell function).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Frequency of Mucosal Associated Invariant T (MAIT) Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet and will not receive the supplement for 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'after 4 weeks', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in MAIT cell frequency (as measured by % of CD3 T cells that are MAIT cells) before and after the interventions', 'unitOfMeasure': 'percentage of CD3 T cells', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Function of Mucosal Associated Invariant T (MAIT) Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet for 4 weeks.'}], 'classes': [{'title': 'before', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'after', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in % of MAIT cell with CD25 function before and after the interventions', 'unitOfMeasure': 'percentage of MAIT cells', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes in Phenotype of Mucosal Associated Invariant T (MAIT) Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supplement Intervention and Control Diet', 'description': 'This group will consume the supplement daily for 4 weeks along with following the diabetic diet.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'OG001', 'title': 'Control Diet Alone', 'description': 'This group will only follow the diabetic diet for 4 weeks.'}], 'classes': [{'title': 'before', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'after', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '9.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in % of MAIT cells with a BCL2-GzB+ phenotype before and after the interventions', 'unitOfMeasure': 'percentage of MAIT cells', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supplement Intervention and Control Diet, Then Control Diet Alone', 'description': 'This group will first consume the supplement daily for 4 weeks in addition to the control diet and then cross-over to control diet alone.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'FG001', 'title': 'Control Diet Alone, Then Supplement Intervention and Control Diet', 'description': 'This arm will start with the control diet alone then cross over to receive the supplement for 4 weeks in addition to the control diet.'}], 'periods': [{'title': 'Baseline-Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Cross-over', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'This arm will consume the supplement daily for 4 weeks.\n\nAcetylated and Butyrylated High Amylose Maize Starch: Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'This arm will not receive the supplement for 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.98', 'spread': '1.92', 'groupId': 'BG000'}, {'value': '13.58', 'spread': '1.07', 'groupId': 'BG001'}, {'value': '14.28', 'spread': '1.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-11', 'size': 742532, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-23T09:36', 'hasProtocol': True}, {'date': '2022-08-25', 'size': 346583, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-09-16T13:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2019-09-30', 'resultsFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-15', 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in Frequency of Mucosal Associated Invariant T (MAIT) Cells', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in MAIT cell frequency (as measured by % of CD3 T cells that are MAIT cells) before and after the interventions'}, {'measure': 'Changes in Function of Mucosal Associated Invariant T (MAIT) Cells', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in % of MAIT cell with CD25 function before and after the interventions'}, {'measure': 'Changes in Phenotype of Mucosal Associated Invariant T (MAIT) Cells', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare changes in % of MAIT cells with a BCL2-GzB+ phenotype before and after the interventions'}], 'primaryOutcomes': [{'measure': 'Change in the Gut Microbiome Profile', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We planned to assess the effect of administering acetylated and butyrylated high amylose maize starch (HAMS-AB) on the gut microbiome profile in people with recently-diagnosed type 1 diabetes (T1D) by sequencing the gut microbiome profile.\n\nThis measure was assesed using the absolute abundance of certain bacterial species of interest.\n\nThe changes will be compared before and after each 4 week time period.'}], 'secondaryOutcomes': [{'measure': 'Changes in the Short Chain Fatty Acid Levels in the Gut.', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'Measurement of Short Chain Fatty Acid Levels in the Stools.'}, {'measure': 'Changes in Average Glucose', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare average glucose changes pre/post intervention with HAMS-AB. We will compare their glycemic changes using continuous glucose monitoring data.'}, {'measure': 'C-peptide Levels (Changes in Beta Cell Health).', 'timeFrame': 'before and after completion of each 4 week sequence', 'description': 'We will compare β-cell measures pre/post intervention with HAMS-AB and between the intervention and control groups. We will assess β-cell function using mixed meal tolerance-derived C-peptide measurements ( a measure of β-cell function).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '37626387', 'type': 'DERIVED', 'citation': 'Ismail HM, Spall M, Evans-Molina C, DiMeglio LA. Evaluating the effect of prebiotics on the gut microbiome profile and beta cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):150. doi: 10.1186/s40814-023-01373-4.'}]}, 'descriptionModule': {'briefSummary': 'Data suggest that intestinal microbiota might be critically involved both in autoimmunity and in glucose homeostasis. An acetylated and butyrylated form of high amylose maize starch (HAMS-AB) that increases beneficial short chain fatty acid (SCFA) production has been safe and effective in disease prevention in mouse type 1 diabetes (T1D) models. The objective of this application is to assess the effect of administering a prebiotic, such as HAMS- AB, on the gut microbiome profile, glycemia and β-cell function in humans with T1D.', 'detailedDescription': 'This is a pilot, single center clinical trial to evaluate the effect of using the prebiotic, HAMS-AB, on the gut microbiome profile, glycemia and β-cell function in children and adolescents ages 12-16 years with recently diagnosed type 1 diabetes.\n\nApproximately 12 participants will be randomized to first to take the supplement and follow the diabetic diet or follow a diabetic diet alone for 4 weeks and then cross-over after a 4 week washout period.\n\nThe primary objective is to determine the effect of using the prebiotic on the gut microbiome profile in youth with T1D.\n\nThe secondary objectives are to determine the effect of using the prebiotic on SCFA production, glycemia and β-cell health and function.\n\nExploratory outcomes include changes in MAIT cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be between 11-17 years of age\n* Willing to consume HAMS-AB and follow a diabetic diet\n* Diagnosed by American Diabetes Association criteria with T1D in the last 4-36 months\n* Random non-fasting C-peptide of 0.17nmol/ml or greater\n* Willing to use an effective form of contraception if sexually active\n* BMI\\< 85% for age and sex\n* Positive for any one of the following diabetes-related autoantibodies that are tested clinically \\[insulin autoantibody (if tested within 14 days of diagnosis), glutamic acid decarboxylase (GAD), insulinoma-associated protein-2 (IA-2), or Zinc transporter 8 autoantibodies (ZnT8)\\].\n\nExclusion Criteria:\n\n1. Presence of severe, active disease that interferes with dietary intake or requires the use of chronic medication, except for well-controlled hypothyroidism and mild asthma not requiring oral steroids.\n2. Diabetes other than T1D (Known monogenic forms of diabetes, Type 2 diabetes)\n3. Chronic illness known to affect glucose metabolism (e.g. Cushing syndrome, polycystic ovarian disorder, cystic fibrosis) or taking medications that affect glucose metabolism (e.g. steroids, metformin)\n4. Psychiatric impairment or current use of anti-psychotic medication\n5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.\n6. Female participants of child-bearing age with reproductive potential, must not be pregnant and agree to use an effective form of birth control or be abstinent during the study period (see below)\n7. History of recurrent infections\n8. History of on-going infections or antibiotic treatment within the past three months\n9. History of immune compromise\n10. Steroid intake (inhaled or oral)\n11. Other immunosuppressant use in past 6 months\n12. History of gastrointestinal disease\n13. Possible or confirmed celiac disease\n14. Pregnancy or possible pregnancy\n15. Allergy to corn (prebiotic)\n16. Allergy to milk or milk products or soy present in Boost\n17. Participation in other intervention research trials within the past 3 months\n18. Anticipate major changes in diabetes management during study (change from injection to pump, new start of continuous glucose monitoring)\n19. Consuming high fiber or vegetarian diet (consuming three or more servings of high fiber foods on 4 or more days per week) using validated dietary assessments (see below under schedule of events table).\n20. Taking fiber supplements\n\n \\-"}, 'identificationModule': {'nctId': 'NCT04114357', 'briefTitle': 'Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Evaluating the Effect of Prebiotics on the Gut Microbiome Profile and Beta Cell Function in Newly Diagnosed Type 1 Diabetes', 'orgStudyIdInfo': {'id': '1907172784'}, 'secondaryIdInfos': [{'id': 'KL2TR002530', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR002530', 'type': 'NIH'}, {'id': 'UL1TR002529', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002529', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supplement Intervention and Control Diet, then Control Diet Alone', 'description': 'This group will first consume the supplement daily for 4 weeks in addition to the diabetic diet then cross-over to follow the diabetic diet for 4 weeks.', 'interventionNames': ['Drug: Acetylated and Butyrylated High Amylose Maize Starch']}, {'type': 'NO_INTERVENTION', 'label': 'Control Diet Alone, then Supplement Intervention and Control Diet', 'description': 'This group will follow the control diet for 4 weeks first then cross-over to receive the supplement for 4 weeks in addition to the diabetic diet.'}], 'interventions': [{'name': 'Acetylated and Butyrylated High Amylose Maize Starch', 'type': 'DRUG', 'otherNames': ['Hylon™ VII Butyrate, Hylon™ VII Acetate'], 'description': 'Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner for 4 weeks', 'armGroupLabels': ['Supplement Intervention and Control Diet, then Control Diet Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Heba M. Ismail', 'investigatorAffiliation': 'Indiana University'}}}}