Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04596605
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2020-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastrointestinal Tolerance Assessment of T2309
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-06-06', 'releaseDate': '2022-07-21'}, {'resetDate': '2024-02-08', 'releaseDate': '2023-06-16'}], 'estimatedResultsFirstSubmitDate': '2022-07-21'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2020-10-14', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastrointestinal Tolerance assessment', 'timeFrame': '12-week', 'description': 'Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the Bristol Stool Scale (BSS) (composite score of stool frequency and consistency) and 10-point Likert scales filled (sum of the ratings of the 4 gastrointestinal symptoms scores) daily for 1 week prior to the completion of the 12-week treatment period (expressed in arbitrary unit/day (a.u./day), range 0-50)'}], 'secondaryOutcomes': [{'measure': 'Composite score of gastrointestinal tolerance', 'timeFrame': '6 weeks', 'description': 'Change from baseline in the mean of the daily composite score of gastrointestinal tolerance assessed with the BSS and 10-point Likert scales filled daily for 1 week prior to the completion of the 6-week treatment period (a.u./day, range 0-50)'}, {'measure': 'Each component of the composite score of gastrointestinal tolerance', 'timeFrame': '6 weeks and 12 weeks', 'description': 'Change from baseline in the mean of each component of the composite score of gastrointestinal tolerance after 6 weeks and 12 weeks of treatment: 4 gastrointestinal symptoms (a.u./day, range 0-10), stool frequency (number of stools/day), stool consistency (a.u./stool, range 1-7)'}, {'measure': 'Acceptability', 'timeFrame': '6 weeks and 12 weeks', 'description': 'Assessed by a self-questionnaire to measure the global satisfaction (4-point scales)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Subjects']}, 'descriptionModule': {'briefSummary': 'Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent signed and dated\n* Volunteer with no history of gastrointestinal disorders\n* Volunteer agreeing not to consume a food supplement other than IP during the study period\n* Registered, or agreeing to be registered, in the National Registry of Healthy Volunteers\n\nExclusion Criteria:\n\n* Any known or suspected hypersensitivity or allergy\n* History of or active severe chronic disease or relevant systemic condition incompatible with the study\n* Pregnancy or breast-feeding or have planned pregnancy in the next 4 months\n* Childbearing potential woman neither surgically sterilized nor using an adequate contraception\n* Inability of the subject to understand the study procedures or to give informed consent\n* Non-compliant subject\n* Participation in this study at the same time as another clinical investigation/study\n* Subject having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros\n* Subject being institutionalized because of legal or regulatory order, inmate of psychiatric wards, prison or state institutions, or employee of the study site or of the Sponsor's company\n* Subject not covered by the government health care scheme of the country in which he/she is living\n* Subject with previous, current or anticipated prohibited treatment"}, 'identificationModule': {'nctId': 'NCT04596605', 'acronym': 'GATA', 'briefTitle': 'Gastrointestinal Tolerance Assessment of T2309', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Thea'}, 'officialTitle': 'Gastrointestinal Tolerance Assessment of T2309', 'orgStudyIdInfo': {'id': 'LT2309-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T2309', 'description': '4 capsules daily for 12 weeks', 'interventionNames': ['Other: T2309']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrof Total', 'description': '2 capsules daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Nutrof Total']}], 'interventions': [{'name': 'T2309', 'type': 'OTHER', 'description': 'Food for Special Medical Purpose / 4 capsules daily for 12 weeks', 'armGroupLabels': ['T2309']}, {'name': 'Nutrof Total', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Food Supplement'], 'description': '2 capsules daily for 12 weeks', 'armGroupLabels': ['Nutrof Total']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Centre Investigation Clinique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Thea', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-21', 'type': 'RELEASE'}, {'date': '2023-06-06', 'type': 'RESET'}, {'date': '2023-06-16', 'type': 'RELEASE'}, {'date': '2024-02-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Laboratoires Thea'}}}}