Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:37 AM
Study NCT ID:
NCT04348760
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BAFF levels', 'timeFrame': '6 weeks', 'description': 'reduction of BAFF levels from baseline'}, {'measure': 'PAF levels', 'timeFrame': '6 weeks', 'description': 'reduction of PAF levels from baseline'}], 'secondaryOutcomes': [{'measure': 'IBS symptom severity', 'timeFrame': '6 weeks', 'description': 'IBS symptom severity score reduction from baseline'}, {'measure': 'BMI', 'timeFrame': '6 weeks', 'description': 'BMI reduction from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IBS - Irritable Bowel Syndrome', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '30288077', 'type': 'BACKGROUND', 'citation': 'Ng QX, Soh AYS, Loke W, Lim DY, Yeo WS. The role of inflammation in irritable bowel syndrome (IBS). J Inflamm Res. 2018 Sep 21;11:345-349. doi: 10.2147/JIR.S174982. eCollection 2018.'}, {'pmid': '20353497', 'type': 'BACKGROUND', 'citation': 'Lied GA, Lillestol K, Valeur J, Berstad A. Intestinal B cell-activating factor: an indicator of non-IgE-mediated hypersensitivity reactions to food? Aliment Pharmacol Ther. 2010 Jul;32(1):66-73. doi: 10.1111/j.1365-2036.2010.04314.x. Epub 2010 Mar 26.'}, {'pmid': '23170971', 'type': 'BACKGROUND', 'citation': 'Ligaarden SC, Lydersen S, Farup PG. IgG and IgG4 antibodies in subjects with irritable bowel syndrome: a case control study in the general population. BMC Gastroenterol. 2012 Nov 21;12:166. doi: 10.1186/1471-230X-12-166.'}, {'pmid': '33292297', 'type': 'DERIVED', 'citation': 'Cappelletti M, Tognon E, Vona L, Basello K, Costanzi A, Speciani MC, Speciani AF. Food-specific serum IgG and symptom reduction with a personalized, unrestricted-calorie diet of six weeks in Irritable Bowel Syndrome (IBS). Nutr Metab (Lond). 2020 Dec 1;17(1):101. doi: 10.1186/s12986-020-00528-x.'}]}, 'descriptionModule': {'briefSummary': 'Irritable Bowel Syndrome (IBS) is a widespread disease with variable symptoms that have an important impact on the quality of life. Despite the prevalence of IBS, its etiology and pathophysiology are still to be fully understood, but immune response is known to be involved. In this study, the investigators researched the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS), following a personalized an unrestricted-calorie diet.', 'detailedDescription': 'The investigators enrolled 30 subjects with diagnosis of IBS, according to Rome-IV criteria, whose inflammatory markers were measured at baseline and after 6 weeks of dietary intervention. The subjects were monitored in a general practice outpatient setting (GP) and nutritional advice was offered remotely via two telephone sessions with a nutritionist. The researchers investigated the variation of two specific cytokines, B-cell activating factor (BAFF) and platelet-activating factor (PAF), the levels of food-specific IgG and the symptom severity, using Irritable Bowel Syndrome - Symptom Severity Score (IBS-SSS).\n\nData monitoring was ensured by an external monitor (Hippocrates Research, Genova, Italy).\n\nAll data entry was in accordance with GCP protocol, and AE were classified using CTCAE 4.0'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IBS (according to ROME IV criteria)\n* blood analysis within 1yr with CBC, TSHr, ESR, CRP, urine, glucose\n* attitude to change dietary habits\n* willing to follow study protocol\n\nExclusion Criteria:\n\n* low BMI (\\<18.5 kg/m2)\n* pregnancy\n* restrictive dietary habits (e.g. veganism)\n* positive FOBT\n* faecal calprotectin \\>200 mcg/g\n* known or recurrent bowel infections\n* known or recurrent UTI (\\>3/yr)\n* former diverticulitis\n* alcohol abuse\n* major concurrent disease (e.g. IBD, coeliac disease, eating disorder,...)\n* pharmacological treatment with drugs that alter intestinal motility (e.g. PPI, metformin,...)'}, 'identificationModule': {'nctId': 'NCT04348760', 'briefTitle': 'Study of Inflammatory Markers and Symptom Severity in Personalized Nutritional Intervention in IBS', 'organization': {'class': 'INDUSTRY', 'fullName': 'GEK Srl'}, 'officialTitle': 'Study of Two Inflammatory Cytokines, BAFF and PAF, and Their Clinical Relevance Before and After a Personalized Nutritional Intervention in IBS Subjects', 'orgStudyIdInfo': {'id': '2019_01_IBS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week', 'interventionNames': ['Behavioral: Rotation Diet']}], 'interventions': [{'name': 'Rotation Diet', 'type': 'BEHAVIORAL', 'description': 'Based on the food-specific IgG measurement and relative distribution, a personalized food profile was created for each subject identifying 1 to 3 relevant food groups/nutritional clusters. Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week. No calorie restriction was imposed in the diet.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'GEK srl', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Emiliana Tognon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GEK Srl'}, {'name': 'Mattia Cappelletti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMA srl'}, {'name': 'Attilio F Speciani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GEK Srl'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'immediately following and for 36 months after publication', 'ipdSharing': 'YES', 'description': 'Individual participants data that underline the results reported in article, after deidentification (text, tables)', 'accessCriteria': 'Proposals should be directed to the PI/Sponsor. To gain access, data requestors will need to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GEK Srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hippocrates Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}