Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-22 @ 2:16 PM
Study NCT ID:
NCT02220166
Status:
COMPLETED
Last Update Posted:
2014-08-19
First Post:
2014-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-18', 'lastUpdatePostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serological: test for immunoglobulin A anti tissue transglutaminases and anti-endomysial', 'timeFrame': 'Baseline, Day 30, Day 60'}], 'primaryOutcomes': [{'measure': 'Histologic: 4 duodenal biopsies obtained and classified according to Marsh', 'timeFrame': 'Baseline, Day 60', 'description': 'After 60 days of daily administration of Tm endoscopic biopsies were performed and reviewed by the same experienced pathologist'}], 'secondaryOutcomes': [{'measure': 'Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': 'Baseline, Day 30, Day 60'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Celiac Disease', 'Gluten', 'Gluten free diet', 'Triticum monococcum'], 'conditions': ['Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '23706063', 'type': 'BACKGROUND', 'citation': 'Zanini B, Petroboni B, Not T, Di Toro N, Villanacci V, Lanzarotto F, Pogna N, Ricci C, Lanzini A. Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease. BMC Gastroenterol. 2013 May 24;13:92. doi: 10.1186/1471-230X-13-92.'}]}, 'descriptionModule': {'briefSummary': 'Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and other suggestive of toxicity. We recently reported results of a single administration of 2.5 grams of Tm in 12 Celiacs in remission on Gluten Free Diet (GFD), while assessing symptoms and changes of intestinal permeability. Although results of intestinal permeability were inconclusive Tm, but not other type of gluten, was clinically well tolerated.\n\nThe aim of the present study was to assess safety of 60 days of administration of Tm (100 grams of water biscuits per day accounting for about 6 grams of gluten from Tm) as judged on clinical, serological and histological parameters in Celiac Disease patients on remission after 1 year of GFD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Celiac patients on Gluten Free Diet (GFD) for at least one year\n* Strict adherence to GFD\n* Negative Celiac related serology\n* Normal duodenal Histology defined as Marsh Class 0-II\n* Willing to participate and adhere to study protocol\n* Sign of the informed consent\n\nExclusion Criteria:\n\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02220166', 'briefTitle': 'Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Phase II Study on Safety of 60 Days Administration of Triticum Monococcum in Patients With Celiac Disease on Remission in Gluten Free Diet', 'orgStudyIdInfo': {'id': 'GE-GA2-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triticum monococcum', 'description': '60 days of daily administration of 100 grams of water biscuits of Triticum monococcum', 'interventionNames': ['Dietary Supplement: Triticum monococcum']}], 'interventions': [{'name': 'Triticum monococcum', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Triticum monococcum']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'I-25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'AO Spedali Civili of Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Alberto Lanzini, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Università degli Studi di Brescia'}, {'name': 'Barbara Zanini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Brescia'}]}, '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'}}}}