Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-31 @ 12:37 PM
Study NCT ID:
NCT04903600
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-12', 'studyFirstSubmitDate': '2021-05-23', 'studyFirstSubmitQcDate': '2021-05-23', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline serum TNF-α at week 12', 'timeFrame': 'Week0, Week12', 'description': 'Compared the difference of serum cytokine TNF-α level between the week 12 and 0'}, {'measure': 'Change from baseline serum IL-6 at week 12', 'timeFrame': 'Week0, Week12', 'description': 'Compared the difference of serum IL-6 level between the week 12 and 0'}, {'measure': 'Change from baseline serum IL-10 at week 12', 'timeFrame': 'Week0, Week12', 'description': 'Compared the difference of serum IL-10 level between the week 12 and 0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of probiotics product (probiotics fruit vegetable fiber powder) on intestinal health and immune system improvement in adults', 'detailedDescription': 'This 12 weeks randomized, single-blind and placebo-controlled study will be conduct in fifty adults. Subjects will be recruited and assigned into two groups in a 1:1 ratio (placebo, n = 25; probiotics, n=25). During the 12 weeks intervention, the subjects should take 32 g powder of placebo or probiotics product (eat 16 g for once, and twice a day). The two powder supplied in an aluminum sachet, and all products were identical in taste. Subjects also should complete the assessment of anthropometric measurement, health conditions, food record, and sample collection (feces and blood) at week 0, 4, 8 and week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Inclusion criteria include male or female participants to be aged 20-60 years old, who had colds more than four times in the past year or had gastric Infection by Helicobacter pylori or peptic ulcer, body mass index within a healthy range (18.5-27 kg/m2) and willing to commit throughout the experiment.\n\nExclusion Criteria:\n\n* Exclusion criteria included cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity, have systemic infections, use probiotics, prebiotics, fruit vegetable fiber supplementation, and lactose Intolerance or cow's milk allergic. Individuals who, in opinion of the investigator, seemed unlikely to complete the trial were also excluded."}, 'identificationModule': {'nctId': 'NCT04903600', 'briefTitle': 'Efficacy Assessment of Probiotics Product on Intestinal Health and Immune System Improvement', 'organization': {'class': 'OTHER', 'fullName': 'Chung Shan Medical University'}, 'officialTitle': 'Efficacy Assessment of Probiotics Fruit Vegetable Fiber Powder on Intestinal Health and Immune System Improvement in Human Trial', 'orgStudyIdInfo': {'id': 'CS2-21043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': '32g probiotics fruit vegetable fiber powder product contained 1.12\\*10(11) CFU of probiotics for 12 weeks', 'interventionNames': ['Dietary Supplement: Probiotics fruit vegetable fiber powder product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '32g placebo contained only maltodextrin (100%) for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotics fruit vegetable fiber powder product', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotics'], 'description': 'Eat 16 g for once, and twice a day', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eat 16 g for once, and twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '402', 'city': 'Taichung', 'state': 'South', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chin-Lin Hsu, Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022', 'phoneExt': '12222'}], 'facility': 'Chung Shan Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chin-Lin Hsu, Professor', 'role': 'CONTACT', 'email': 'clhsu@csmu.edu.tw', 'phone': '04-24730022', 'phoneExt': '12222'}], 'overallOfficials': [{'name': 'Yu-Jou Chien, PhD Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}, {'name': 'Ying-Chi Chen, MS Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung Shan Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'TCI Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chin-Lin Hsu', 'investigatorAffiliation': 'Chung Shan Medical University'}}}}