Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT03268720
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2017-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of the Immunosystem in Non-celiac Glutensensitivity
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': 'D000092622', 'term': 'FODMAP Diet'}, {'id': 'D055050', 'term': 'Diet, Gluten-Free'}], 'ancestors': [{'id': 'D000092724', 'term': 'Elimination Diets'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants consume a two week lasting low FODMAP diet, followed by 5 days washout, and subsequent two week gluten-free diet.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2017-08-15', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of clinical symptomatics', 'timeFrame': '2 weeks', 'description': 'Analysis of the improvement of clinical symptoms according to gastrointestinal symptom Rating score'}, {'measure': 'Determination of psychological symptoms', 'timeFrame': '2 weeks', 'description': 'Improvement of well-being by questionnaire psychological General well-being index'}], 'secondaryOutcomes': [{'measure': 'Nutrition Analysis for energy intake and nutritional composition by questionnaire Freiburger Nutrition protocol', 'timeFrame': '2 weeks', 'description': 'Determination of nutrient intake according to questionnaire Freiburger Nutrition protocol. The questionnaire allows the detailed determination of energy intake, carbohydrates, fatty acids, and Protein.'}, {'measure': 'Intraepithelial lymphocytes', 'timeFrame': '4 weeks', 'description': 'numbers of intraepithelial lymphocytes in duodenal mucosa'}, {'measure': 'Goblet cells', 'timeFrame': '4 weeks', 'description': 'numbers of Goblet cells in duodenal mucosa'}, {'measure': 'microbiome', 'timeFrame': '2 weeks', 'description': 'Analysis of microbiota pattern'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gluten sensitivity', 'gluten-free diet', 'FODMAP diet', 'microbiome'], 'conditions': ['Gluten Sensitivity']}, 'referencesModule': {'references': [{'pmid': '29653862', 'type': 'DERIVED', 'citation': 'Dieterich W, Schuppan D, Schink M, Schwappacher R, Wirtz S, Agaimy A, Neurath MF, Zopf Y. Influence of low FODMAP and gluten-free diets on disease activity and intestinal microbiota in patients with non-celiac gluten sensitivity. Clin Nutr. 2019 Apr;38(2):697-707. doi: 10.1016/j.clnu.2018.03.017. Epub 2018 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.', 'detailedDescription': 'Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat specific IgE are done.\n\nAfter exclusion of celiac disease and wheat allergy patients are considered as patients with NCGS.\n\nPatients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet.\n\nAt the beginning and the end of each diet the participants fill in questionnaires concerning Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB), gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart). Furthermore, stool samples are selected at each time point to determine the microbial pattern.\n\nNCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy controls\n* patients with glutensensitivity\n\nExclusion Criteria:\n\n* patients with glutensensitivity but without celiac disease or wheat allergy'}, 'identificationModule': {'nctId': 'NCT03268720', 'acronym': 'NCGS', 'briefTitle': 'Influence of the Immunosystem in Non-celiac Glutensensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Influence of the Immunosystem in Non-celiac Glutensensitivity', 'orgStudyIdInfo': {'id': 'Glutensensitivity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'healthy controls', 'description': 'FODMAP low diet gluten-free diet', 'interventionNames': ['Other: FODMAP low diet', 'Other: gluten-free diet']}, {'type': 'OTHER', 'label': 'NCGS patients', 'description': 'FODMAP low diet gluten-free diet', 'interventionNames': ['Other: FODMAP low diet', 'Other: gluten-free diet']}], 'interventions': [{'name': 'FODMAP low diet', 'type': 'OTHER', 'description': '2 week FODMAP low diet', 'armGroupLabels': ['NCGS patients', 'healthy controls']}, {'name': 'gluten-free diet', 'type': 'OTHER', 'description': '2 week gluten-free diet', 'armGroupLabels': ['NCGS patients', 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'yurdagül zopf', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}