Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-01-27 @ 3:08 AM
Study NCT ID:
NCT04891666
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2021-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of blood lead levels', 'timeFrame': '12 weeks', 'description': 'Difference in reduction of blood lead level between the experimental group and the placebo group at week 12 compared with baseline'}], 'secondaryOutcomes': [{'measure': 'Reduction of blood lead levels', 'timeFrame': '4 and 8 weeks', 'description': 'Compared with the baseline, the difference between the reduction of the blood lead level in the experimental group and the placebo group at the 4th and 8th week'}, {'measure': 'Reduction of urine lead levels', 'timeFrame': '4, 8 and 12 weeks', 'description': 'Compared with baseline, the difference between the reduction of urine lead levels in the experimental group and the placebo group at the 4th, 8th, and 12th week'}, {'measure': 'Improvement of common trace elements-Ca,Zn,Cu,Mg,Fe in the blood', 'timeFrame': '4, 8 and 12 weeks', 'description': 'Compared with baseline, the difference between the improvement of common trace elements Ca,Zn,Cu,Mg,Fe in the blood of the experimental group and the placebo group at the 4th, 12th and 24th week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elevated Blood Lead Levels']}, 'referencesModule': {'references': [{'pmid': '40959702', 'type': 'DERIVED', 'citation': 'Ji W, Saulnier DM, Zhang L, Liu J, Gao J, Wang X, Holz C, Liang A, Tan HT. Effects of Lactiplantibacillus plantarum DSM 33464 in children with elevated blood lead levels: a randomized, double-blind, placebo-controlled study. Front Nutr. 2025 Sep 1;12:1641839. doi: 10.3389/fnut.2025.1641839. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The study is a parallel, randomized, double-blind, placebo controlled clinical trial will evaluate the effect of Lactobacillus plantarum DSM 33464 on reduction of Blood lead levels and general well-being of children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe subjects who meet all of the following selection criteria can participate in this study:\n\n1. Children age 3-12 years\n2. BLL 35-249 µg/L\n3. Subjects, their parents or legal guardians are able and willing to comply with research guidance\n4. Subject's parents or legal guardians sign written informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria may not participate in this study:\n\n1. Diagnosed with nervous system diseases, genetic and metabolic diseases, endocrine diseases, lung diseases, severe or unstable cardiovascular diseases, clinically significant kidney or liver diseases, blood system diseases, any other clinically significant diseases and Other investigators judge that the participation of subjects in the study will increase the risk of the subjects' diseases;\n2. History of infection or organ transplantation of human immunodeficiency virus or other acquired congenital immunodeficiency diseases;\n3. Take probiotic products in the last two weeks\n4. Known or suspected sensitivity or allergy to food or any constituents tested in the trial\n5. Participation in another clinical trial or food study 4 weeks prior and during the trial"}, 'identificationModule': {'nctId': 'NCT04891666', 'briefTitle': 'A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novozymes A/S'}, 'officialTitle': 'A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard®) on Blood Lead Levels in Children', 'orgStudyIdInfo': {'id': 'NZ-GHSG-2020-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus plantarum DSM 33464', 'description': '1 sachet of Lactobacillus plantarum DSM 33464 (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum DSM 33464']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '1 sachet of placebo (2 g) and 1 sachet of supplement YingKangWei per day for 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum DSM 33464', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['SmartGuard®'], 'description': '1 sachet SmartGuard® per day for 12 weeks', 'armGroupLabels': ['Lactobacillus plantarum DSM 33464']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 sachet of placebo per day for 12 weeks', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Baoding', 'state': 'Hebei', 'country': 'China', 'facility': "Baoding children's hospital", 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': "Children's Hospital of Heibei Province", 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Xuzhou children's Hospital", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Chengdu women's and children's Central Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novozymes A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': "Baoding Children's Hospital", 'class': 'OTHER'}, {'name': 'Xuzhou Children Hospital', 'class': 'OTHER'}, {'name': "Chengdu Women's and Children's Central Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital of Heibei Province", 'class': 'UNKNOWN'}, {'name': 'Beijing Clinical Service Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}