Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-03-09 @ 8:12 PM
Study NCT ID:
NCT04340661
Status:
TERMINATED
Last Update Posted:
2023-04-18
First Post:
2019-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2019-09-03', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in fecal Microbiota composition', 'timeFrame': '4 weeks', 'description': 'relative abundance of bacteroidetes'}], 'secondaryOutcomes': [{'measure': 'Changes in circulating cytokines and chemokines', 'timeFrame': '4 weeks', 'description': 'IL-1β, IL-4, IL-6, IL-10,IL-17A,IL-17F, IL-21, IL-22, IL-23, IL-25, IL31, IL-33, IFN-γ, MIP-1b , MCP-1 cytokines and chemokines will be evaluated'}, {'measure': 'Irritable Bowel Syndrome-Visual Analogue Scale (IBS-VAS) score improvement', 'timeFrame': '4 weeks', 'description': 'Irritable Bowel Syndrome-Visual Analogue Scale is designed to measure the treatment response of symptoms and well-being in patients suffering from IBS. It is composed by 4 items:\n\n1\\) abdominal pain, 2) Abnominal bloating, 3) Satisfaction of the intestinal habits 4) influence on daily life. The patients are asked to record in the VAS-IBS the overall severity of each of the 4 items on a 100-mm-long horizontal line ("very severe discomfort 0" to "no discomfort at all 100").'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiota', 'immune system'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this double blind placebo-controlled study is to evaluate the effect of BIOintestil on fecal microbiota, inflammatory chemokines and symptoms in patients affected by Irritable Bowel Syndrome (IBS).', 'detailedDescription': 'BIOintestil is a dietary supplement based on Palmrose oil (Cymbopogon martinii) and ginger ryzoma powder. Palmrose oil effects were already established in animal model of colitis and in a pilot study on patients with IBS. In this study, 108 patients will be randomized to receive BIOintestil or placebo in a 1:1 ratio, for four weeks. Fecal and blood samples will be collected at each visit for microbiota and chemokine analysis, patients syntoms will be evaluated by administration of the validated IBS-VAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* willing of sign written informed consent;\n* participants affected with Irritable bowel syndrome (IBS) who satisfy Rome III criterias for diagnosis\n* body weight between 48 and 104 kg, with a BMI less than 27\n* age between 18 and 65 years old\n\nExclusion Criteria:\n\n* participants that have not taken following medications within 30 days before randomization: steroidal anti-inflammatory drugs, antibiotics or supplemntes or functional foods that may contain probiotics or prebiotics\n* women who suspect to be/are pregnant or in lactacy\n* participants with Inflammatory bowel disease disgnosis or celiac disease or severe systemic disease\n* participants who are intolerant to lactose or with food allergies confirmed\n* particpiants with confirmed or suspected hypersensibility to one or more of Bionocol® components\n* participants with severe concomitants disease that, by investigator's opinion, interfere with study partecipation\n* participants under anticoagulant therapy or with coagulation disease\n* participants with renal and hepatic failure\n* participants who have taken any investigational drug within 2 month the randomization visit"}, 'identificationModule': {'nctId': 'NCT04340661', 'briefTitle': 'Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Targeting Gut Disease S.R.L.'}, 'officialTitle': 'Effects of a Food Supplement Composed by BIOintestil ® (Bionocol®) on Microbiota and Inflammatory Profile in Irritable Bowel Syndrome Patients', 'orgStudyIdInfo': {'id': 'TGD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bionocol arm', 'interventionNames': ['Dietary Supplement: BIOintestil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'interventionNames': ['Dietary Supplement: PLACEBO']}], 'interventions': [{'name': 'BIOintestil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BIONOCOL'], 'description': 'Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)', 'armGroupLabels': ['Bionocol arm']}, {'name': 'PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cornstarch', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'A.O.U Policlinico S.Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Fernando Rizzello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O.U Policlinico S.Orsola-Malpighi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Targeting Gut Disease S.R.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}