Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 10:17 PM
Study NCT ID:
NCT05744258
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2023-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sebastien.kindt@uzbrussel.be', 'phone': '+32 2 477 60 11', 'title': 'prof. dr. Sebastien Kindt', 'organization': 'UZ Brussel'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'from enrollment until end of follow up, up to 1 week', 'description': "safety was checked for all patients, however every patient only performed 1 visit. They were followed until 1 week after that visit regarding safety but no AE's, SAE's or deaths occurred.", 'eventGroups': [{'id': 'EG000', 'title': 'IBS Patients', 'description': 'participants suffering from IBS', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Volunteers', 'description': 'participants not suffering from IBS', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comparison of the Phase Angle Between IBS Patients and Healthy Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IBS Patients', 'description': 'patients suffering from irritable bowel syndrome'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'participants not suffering from irritable bowel syndrome'}], 'classes': [{'categories': [{'measurements': [{'value': '5.78', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The phase angle will be assessed through study completion, an average 6 months', 'description': 'Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed.\n\nReactance and resistance will be obtained. Phase angle will be calculated according to the formula:\n\nPhA (°) = (reactance/ resistance° x (180°/π).', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IBS Patients', 'description': 'patients suffering from IBS'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'participants not suffering from IBS'}], 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The body composition will be assessed through study completion, an average 6 months', 'description': 'percentage of total body water will be calculated using the measurements obtained during the BIA analysis.', 'unitOfMeasure': '% of total body water', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IBS Patients', 'description': 'patients suffering from IBS'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'participants not suffering from IBS'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '5.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'the muscle mass will be assessed through study completion, an average 6 months', 'description': 'The muscle mass will be calculated using the measurements obtained during the BIA analysis.', 'unitOfMeasure': '% of muscle mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IBS Patients', 'description': 'patients suffering from IBS'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'participants suffering from IBS'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '53.7', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'the percentage of body fat will be assessed through study completion, an average 6 months', 'description': 'percentage of body fat will be calculated using the measurements obtained during the BIA analysis.', 'unitOfMeasure': '% of fat free mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IBS Patients', 'description': 'patients having irritable bowel disease'}, {'id': 'FG001', 'title': 'Healthy Volunteers', 'description': 'participants not having irritable bowel disease or bowel problems'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Our first patient was recruited on the 22nd of August 2022. The last patient entered the study on 15JUN2023. Patients with IBS were recruited at the gastro-enterology department. Healthy volunteers were asked to participate in the hospital.', 'preAssignmentDetails': 'Signing of the ICF, screening and baseline visit were all done on the same day. One patient withdrew consent and was excluded.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IBS Patients', 'description': 'patients having irritable bowel disease'}, {'id': 'BG001', 'title': 'Healthy Volunteers', 'description': 'patients not having irritable bowel disease or any bowel problems'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.23', 'spread': '6.46', 'groupId': 'BG000'}, {'value': '23.77', 'spread': '3.76', 'groupId': 'BG001'}, {'value': '25.54', 'spread': '5.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-19', 'size': 940585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-05T02:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2023-01-27', 'resultsFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-26', 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the Phase Angle Between IBS Patients and Healthy Individuals', 'timeFrame': 'The phase angle will be assessed through study completion, an average 6 months', 'description': 'Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed.\n\nReactance and resistance will be obtained. Phase angle will be calculated according to the formula:\n\nPhA (°) = (reactance/ resistance° x (180°/π).'}, {'measure': 'Comparison of the Percentage of Total Body Water Between IBS Patients and Healthy Individuals', 'timeFrame': 'The body composition will be assessed through study completion, an average 6 months', 'description': 'percentage of total body water will be calculated using the measurements obtained during the BIA analysis.'}, {'measure': 'Comparison of the Muscle Mass Between IBS Patients and Healthy Individuals', 'timeFrame': 'the muscle mass will be assessed through study completion, an average 6 months', 'description': 'The muscle mass will be calculated using the measurements obtained during the BIA analysis.'}, {'measure': 'Comparison of the Percentage of Body Fat Between IBS Patients and Healthy Individuals', 'timeFrame': 'the percentage of body fat will be assessed through study completion, an average 6 months', 'description': 'percentage of body fat will be calculated using the measurements obtained during the BIA analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The study aim is to investigate the Bio-electrical Impedance (BIA) parameters in general, and phase angle (PhA) in particular in Irritable bowel syndrome (IBS) patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.', 'detailedDescription': 'The role and significance of bio-electrical impedance analysis (BIA) has not been studied in IBS. Therefore, The investigators designed this exploratory study to assess its potential role in the diagnosis and follow-up of treatment in IBS. The study aim is to investigate the BIA parameters in general, and PhA in particular in IBS patients and to compare these with values from healthy controls, while assessing the relationship with other confounding parameters in IBS: psychological parameters, physical activity, dietary pattern (with special interest in FODMAP intake). In a second phase, the evolution of the BIA parameters will be analyzed according to response to therapy.\n\nThe primary objective is to compare the BIA parameters including PhA between IBS and healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 - 75 years;\n* Fulfilling the ROME IV criteria for IBS (only for patients);\n\nExclusion Criteria:\n\n* Clinical suspicion of an organic disorder different from IBS (patients can be included when this disorder had been excluded);\n* Known inflammatory bowel disorder;\n* Known major intestinal motility disorder;\n* Alcohol (defined as more than 14 U per week) or other substance abuse;\n* Active psychiatric disorder;\n* Known systemic or auto-immune disorder with implication for the GI system;\n* Prior abdominal surgery (with the exception of cholecystectomy or ap-pendectomy);\n* Any prior diagnosis of cancer other than basocellular carcinoma;\n* Current chemotherapy;\n* History of gastro-enteritis in the past 12 weeks;\n* Dietary supplements unless taken at a stable dose for more than 12 weeks;\n* Treatment with neuromodulators (one neuromodulator taken at a sta-ble dose for more than 12 weeks is allowed);\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05744258', 'acronym': 'BIA-IBS', 'briefTitle': 'The Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'A Prospective Exploratory Study on the Value of Bio-electrical Impedance Analysis in Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'BIA-IBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'IBS patients', 'interventionNames': ['Device: Bio-electrical impedance analysis']}, {'type': 'OTHER', 'label': 'Healthy volunteers', 'interventionNames': ['Device: Bio-electrical impedance analysis']}], 'interventions': [{'name': 'Bio-electrical impedance analysis', 'type': 'DEVICE', 'description': 'Bio-electrical Impedance Analysis will be performed by trained personnel. BIA will be performed after fasting for at least 6 hours. Subjects should refrain from intensive physical activity the day be-fore the measurement. For women, measurements will be performed outside menstruating periods. Subjects will lay down on an examination couch with bare feet. Any jewelry will be removed.\n\nReactance and resistance will be obtained. Phase angle will be calculated according to the formula:\n\nPhA (°) = (reactance/ resistance° x (180°/π). Body composition, including muscle mass and percentage body fat will be calculated.', 'armGroupLabels': ['Healthy volunteers', 'IBS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}