Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 11:00 AM
Study NCT ID:
NCT01864993
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2013-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005983', 'term': 'Glutens'}], 'ancestors': [{'id': 'D055315', 'term': 'Prolamins'}, {'id': 'D000078522', 'term': 'Grain Proteins'}, {'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D055314', 'term': 'Seed Storage Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2013-05-19', 'studyFirstSubmitQcDate': '2013-05-26', 'lastUpdatePostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Visual Analogue Scales', 'timeFrame': '28 days', 'description': 'Symptomatic resolution after the instauration of a gluten free diet will be verified by means of VAS scales'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '28 days', 'description': 'patients with non celiac gluten sensitivity will be evaluated by means of SF36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['non celiac gluten sensitivity', 'gluten', 'irritable bowel syndrome', 'functional disorders'], 'conditions': ['Non Celiac Gluten Sensitivity']}, 'referencesModule': {'references': [{'pmid': '35973395', 'type': 'DERIVED', 'citation': 'Scricciolo A, Lombardo V, Elli L, Bascunan KA, Doneda L, Rinaldi F, Pinto D, Araya M, Costantino A, Vecchi M, Roncoroni L. Use of a proline-specific endopeptidase to reintroduce gluten in patients with non-coeliac gluten sensitivity: A randomized trial. Clin Nutr. 2022 Sep;41(9):2025-2030. doi: 10.1016/j.clnu.2022.07.029. Epub 2022 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'Non Celiac Gluten Sensitivity (NCGS) is an emergent syndrome mainly inducing gastrointestinal symptoms. NCGS is suspected to be present in the 6% of the population and thus it represents an important issue in health care. Actually it remains difficult to diagnose and prove due to the lack of established criteria. The investigators intention is to establish a diagnostic flowchart to evaluate the real impact of NCGS in a cohort of patients suffering from functional gastrointestinal symptoms.', 'detailedDescription': 'The proposed study has been designed to be a randomised double-blind multicenter clinical trial with crossover. The Coordinating Center will be the "Centro per la Prevenzione e la Diagnosi della Malattia Celiaca", Fondazione IRCCS Ca\' Granda - Ospedale Maggiore Policlinico, Milano. Secondary enrollment centers will be Italian Gastroenterology Units with outpatient services. Enrollment criteria will be diagnosis of irritable bowel syndrome (IBS) or functional dyspepsia. Patients with other functional gastrointestinal disorders will be included in the group "Functional non specific gastrointestinal symptoms".\n\nAfter they give their written informed consent, patients will undergo the diagnostic work-up recommended in case of suspected irritable bowel symptoms/functional dyspepsia and aimed at the exclusion of CD or allergy to alimentary antigens by means of serological testing (anti transglutaminase antibodies) or skin tests, or other gastrointestinal diseases. Endoscopic, histologic and/or imaging exams together with supplemental blood tests will be prescribed on individual cases and according with the international guidelines.\n\nEnrolled subjects will be asked to fill\n\n* a checklist for the evaluation of the psychological profile (SCL90 questionnaire, with the particular aim of evaluating levels of anxiety, depression and somatisation);\n* a questionnaire about the perceived level of physical and mental health (SF36 questionnaire);\n* Ten centimeters long visual analogue scales (VAS) on the level of satisfaction with their health status and on the intensity of the single symptoms.\n\nAt the end of the present phase patients will start a GFD for the subsequent three weeks.\n\nAt the end of the GFD period patients will fill VAS and SF36. Only those patients presenting a 30% increase of the global VAS score ("GFD Responders") will continue the study. Conversely, non responders will be considered "non gluten sensitive" and they will finish the trial.\n\nResponders to the GFD period will entry the randomisation phase and will undergo a double-blind stimulation test with cross over. Patients will be randomised to assume gluten or placebo for 7 days. After the treatment patients will fill VAS and SF36.\n\nA diagnosis of NCGS will be ascertained in case of symptomatic response limited to gluten ingestion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with gastrointestinal functional disorders (irritable bowel syndrome, functional dyspepsia or unspecified functional gastrointestinal symptoms)\n\nExclusion Criteria:\n\n* Celiac disease\n* Alimentary allergies\n* Inflammatory bowel disease\n* Major abdominal surgery\n* Psychiatric disorders\n* Neoplasia'}, 'identificationModule': {'nctId': 'NCT01864993', 'acronym': 'Glutox', 'briefTitle': 'Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Glutox Trial. Symptomatic Response to Gluten Challenge in Patients With Suspected Non Celiac Gluten Sensitivity: a Double Blind Crossover Controlled Trial', 'orgStudyIdInfo': {'id': '1876/2012'}, 'secondaryIdInfos': [{'id': '1876', 'type': 'OTHER', 'domain': 'Fondazione IRCCS Cà Granda'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'suspected NC gluten sensitive subjects', 'description': 'Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet', 'interventionNames': ['Dietary Supplement: gluten', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'suspected NC gluten sensitive', 'description': 'Patients referring gastrointestinal functional disorders will be selected and they will follow a gluten free diet', 'interventionNames': ['Dietary Supplement: gluten', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'gluten', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme', 'armGroupLabels': ['suspected NC gluten sensitive', 'suspected NC gluten sensitive subjects']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme', 'armGroupLabels': ['suspected NC gluten sensitive', 'suspected NC gluten sensitive subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26013', 'city': 'Crema', 'state': 'Italy', 'country': 'Italy', 'facility': 'Ospedale Maggiore di Crema', 'geoPoint': {'lat': 45.36264, 'lon': 9.68176}}, {'zip': '32032', 'city': 'Feltre', 'state': 'Italy', 'country': 'Italy', 'facility': 'Ospedale S. Maria', 'geoPoint': {'lat': 46.02085, 'lon': 11.90031}}, {'city': 'Busto Arsizio', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Ospedale Di Busto Arsizio', 'geoPoint': {'lat': 45.61128, 'lon': 8.84914}}, {'city': 'Como', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Ospedale Valduce di Como', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '42122', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Arcispedale S. Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Luca Elli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Cà Granda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Luca Elli', 'investigatorAffiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}}}}