Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT07196735
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-19', 'studyFirstSubmitQcDate': '2025-09-19', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in phase angle between healthy patients and patients with FD', 'timeFrame': 'from signing of the ICF till end of study (on average 1 week)'}, {'measure': 'Difference in fat mass between healthy patients and patients with FD', 'timeFrame': 'from signing of the ICF till end of study (on average 1 week)'}, {'measure': 'Difference in fat free mass between healthy patients and patients with FD', 'timeFrame': 'from signing of the ICF till end of study (on average 1 week)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Dyspepsia', 'BIA', 'Fat Free Mass', 'Fat Mass', 'Phase Angle']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to compare the BIA parameters, including Phase Angle, Fat Free Mass and Fat Mass, between women with functional dyspepsia and healthy women. All woman will undergo a bio-electrical impedance monitoring for this.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'female patients with or without FD between 18 and 75 years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged 18 - 75 years\n* Fulfilling the ROME IV criteria for functional dyspepsia (for FD patients)\n* FD unexplained by upper GI endoscopy during the past 12 months (mild gastritis allowed) (for FD patients).\n\nExclusion Criteria:\n\n* Clinical suspicion of an organic disorder different from FD (patients can be included when this disorder had been excluded);\n* Abnormality on upper GI endoscopy other than mild gastritis (for FD patients).\n* Known reflux oesophagitis Los Angeles grade C or D, known Barrett oesophagus, peptic stricture.\n* H pylori infection, unless treated at least 6 months before;\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* Treatment with PPI's during the past 8 weeks\n* Pregnancy."}, 'identificationModule': {'nctId': 'NCT07196735', 'briefTitle': 'Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Bio-electrical Impedance Analysis in Patients With Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'BIA in FD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with FD'}, {'label': 'healthy patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sebastien Kindt', 'role': 'CONTACT', 'email': 'sebastien.kindt@uzbrussel.be', 'phone': '+3224776011'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Sebastien Kindt', 'role': 'CONTACT', 'email': 'sebastien.kindt@uzbrussel.be', 'phone': '+3224776011'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}