Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-01-02 @ 1:11 AM
Study NCT ID:
NCT01827566
Status:
UNKNOWN
Last Update Posted:
2014-12-08
First Post:
2013-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's ability to correctly identify the phase with gluten", 'timeFrame': 'Time (days) 35', 'description': '* time 0: start of first challenge (phase A, either with gluten or gluten free flour)\n* time 10: end of phase A and start of wash-out period\n* time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)\n* time 35: end of phase B'}], 'secondaryOutcomes': [{'measure': 'Changes in serum level of anti-tissue transglutaminases immunoglobulin A (IgA)/immunoglobulin G (IgG) and of anti-gliadin IgA/IgG', 'timeFrame': 'Time (days) 0, 10, 25, 35', 'description': '* time 0: start of first challenge (phase A, either with gluten or gluten free flour)\n* time 10: end of phase A and start of wash-out period\n* time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)\n* time 35: end of phase B'}, {'measure': 'Change in Fatigue Visual Scale', 'timeFrame': 'Time (days) 0, 10, 25, 35', 'description': '* time 0: start of first challenge (phase A, either with gluten or gluten free flour)\n* time 10: end of phase A and start of wash-out period\n* time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)\n* time 35: end of phase B'}, {'measure': 'Change in Gastrointestinal Rating Score (GSRS) during Challenge with and without gluten', 'timeFrame': 'Time (days) 0,10, 25, 35', 'description': '* Time 0: Start of first challenge (phase A, either with gluten or gluten free flour)\n* Time 10: end of phase A and start of wash-out period\n* Time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)\n* Time 35: end of phase B\n* At the beginning of Low-FODMAPs diet\n* After two months of Low-FODMAPs diet'}, {'measure': "Change in symptoms' score (1 to 7 Likert scale) as recorded on a daily diary", 'timeFrame': 'From Time 0 (days) to 10 and from 25 to 35', 'description': '* time 0: start of first challenge (phase A, either with gluten or gluten free flour)\n* time 10: end of phase A and start of wash-out period\n* time 25: end of wash-out period and start of second challenge (phase B, either with gluten or gluten free flour)\n* time 35: end of phase B'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Celiac Disease', 'Gluten Sensitivity', 'Gluten', 'Double-blind challenge, placebo-controlled challenge', 'Gluten free flour'], 'conditions': ['Non Celiac Gluten Sensitivity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the prevalence of Gluten Sensitivity, by a double-blind placebo-controlled challenge with gluten, followed by two months period of Low-FODMAPs (Fermentable Oligosaccharides Disaccharides Monosaccharides And Polyols) diet, in patients spontaneously adherent to gluten free diet because of symptoms upon gluten exposure and in whom diagnosis of Celiac Disease and Wheat Allergy has been ruled out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adherence to gluten free diet without medical need\n* Negative Celiac Disease related serology (while on gluten containing diet)\n* Normal villous structure at duodenal biopsy (while on gluten containing diet)\n\nExclusion Criteria:\n\n* Diagnosis of Celiac Disease\n* Diagnosis of Wheat Allergy\n* Diagnosis of organic gastrointestinal disease\n* Severe concomitant disease'}, 'identificationModule': {'nctId': 'NCT01827566', 'briefTitle': 'Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial With a Cross-over Design to Assess the Prevalence of Non Celiac Gluten Sensitivity Among Patients Spontaneously Adherent to Gluten Free Diet', 'orgStudyIdInfo': {'id': 'GE-2012-GS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'gluten', 'description': '10 grams of gluten in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet', 'interventionNames': ['Other: gluten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'gluten free flour', 'description': '10 grams of gluten free flour in each sachet to be dispersed daily on food for ten days, while maintaining a gluten free diet', 'interventionNames': ['Other: gluten free flour']}], 'interventions': [{'name': 'gluten', 'type': 'OTHER', 'armGroupLabels': ['gluten']}, {'name': 'gluten free flour', 'type': 'OTHER', 'armGroupLabels': ['gluten free flour']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'I-25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'University and Spedali Civili of Brescia, Unit of Gastroenterology', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Alberto Lanzini, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Brescia, Unit of Gastroenterology'}, {'name': 'Barbara Zanini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Brescia, Unit of Gastroenterology'}, {'name': 'Chiara Ricci, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Brescia, Unit of Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Gastroenterology', 'investigatorFullName': 'Alberto Lanzini, MD PhD', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}