Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-02 @ 12:02 PM
Study NCT ID:
NCT04827368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2021-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum: Will be obtained from whole blood Stool: will be collected using standard collection containers and procedures and aliquoted Breath: Subjects will be nil per orally (NPO) for 8 hours prior to breath collection and they will rinse their mouths and gargle with water immediately before obtaining the breath sample to eliminate contamination from oral VOCs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2021-03-30', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity', 'timeFrame': '1 year', 'description': 'Correlation of breath VOCs with endoscopic disease activity'}], 'primaryOutcomes': [{'measure': 'Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity', 'timeFrame': '1 year', 'description': 'Correlation of breath VOCs with changes in Fecal Calprotectin.'}], 'secondaryOutcomes': [{'measure': 'Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity', 'timeFrame': '1 year', 'description': 'Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD, VOC'], 'conditions': ['IBD', 'Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines.\n\nAt inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed as having Crohn's Disease or Ulcerative Colitis\n* Aged 18-70 years.\n* Understands the language and signs an informed consent form.\n* Any disease location, except isolated upper GI Crohn's disease only\n* Any CD or UC disease activity.\n* Outpatients and inpatients\n* Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.\n\nExclusion Criteria:\n\n* Status post colectomy\n* Status post diverting loop ileostomy or end ileostomy or colostomy\n* On antibiotics in the past 3 months or currently\n* Women (pregnant or breast feeding)\n* Subjects with concurrent chronic liver, renal, lung or metabolic disorders\n* Active malignancy\n* Bowel preparation at day of sample procurement\n* Isolated upper GI Crohn's disease only\n* Active disease on colonoscopy, but normal fecal calprotectin at inclusion\n* C diff. positive at time of inclusion (test to be obtained in routine clinical care)."}, 'identificationModule': {'nctId': 'NCT04827368', 'acronym': 'VOC', 'briefTitle': 'Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds', 'orgStudyIdInfo': {'id': '20-1149'}, 'secondaryIdInfos': [{'id': 'B19-566', 'type': 'OTHER', 'domain': 'Abbvie'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Crohns Disease', 'description': 'Potential participants will be identified based on their planned/scheduled endoscopy visit.', 'interventionNames': ['Other: Breath Test']}, {'label': 'Ulcerative Colitis', 'description': 'Potential participants will be identified based on their planned/scheduled endoscopy visit.', 'interventionNames': ['Other: Breath Test']}, {'label': 'Non-IBD', 'description': 'Healthy subjects with no bowel disorders will be included as controls.', 'interventionNames': ['Other: Breath Test']}], 'interventions': [{'name': 'Breath Test', 'type': 'OTHER', 'otherNames': ['Serum Samples', 'Stool Samples'], 'description': 'Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.', 'armGroupLabels': ['Crohns Disease', 'Non-IBD', 'Ulcerative Colitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Florian Rieder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Florian Rieder', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}