Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 9:25 PM
Study NCT ID:
NCT06837961
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 241}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-02-17', 'studyFirstSubmitQcDate': '2025-02-17', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety: Occurrence of adverse events', 'timeFrame': 'Week 0 to week 4', 'description': 'Occurrence of adverse events'}, {'measure': 'Safety: Confirmation of medical history during study period', 'timeFrame': 'Week 0 to week 4', 'description': 'Confirmation of medical history during study period'}], 'primaryOutcomes': [{'measure': 'The degree of activation of plasmacytoid dendritic cells (pDCs)', 'timeFrame': 'Week 0 to week 4', 'description': 'The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+'}], 'secondaryOutcomes': [{'measure': 'Activation of Cytotoxic T Lymphocytes (CTLs)', 'timeFrame': 'Week 0 to week 4', 'description': 'The evaluation of CTLs responsible for virus elimination will be determined using the indicator (CD8+/CD3+/CD4-/IFN-γ+).'}, {'measure': 'Anti-viral Activity of PBMCs', 'timeFrame': 'Week 0 to week 4', 'description': 'The anti-viral activity gene expression and IFN-α \\& β production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured.'}, {'measure': 'WURSS-24 Symptom Score', 'timeFrame': 'Week 0 to week 4', 'description': 'Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24)'}, {'measure': 'Rapid antigen test (RAT)', 'timeFrame': 'Week 0 to week 4', 'description': 'Rapid antigen test (RAT) for Flu A/B, RSV \\& SARS-CoV-2. Will be conducted by participants once per week, with additional tests if symptoms are present.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LC-Plasma', 'Healthy volunteer'], 'conditions': ['Healthy Volunteer', 'Immune Response']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effects of LC-Plasma on the innate and acquired immune systems, including the activation of pDCs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. Researchers will compare LC-Plasma to placebo, participants will take a tablet containing LC-Plasma or placebo daily for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who can provide a signed and dated informed consent form after confirming their willingness to participate.\n* Individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular RATs.\n* Healthy people living in Australia aged 18-60 (both men and women).\n* Individuals who have received at least two doses of a SARS-CoV-2 vaccine, with at least two weeks having passed since the last dose.\n* Individuals who are not currently infected with SARS-CoV-2 and, if previously infected, have recovered and have been infection-free for at least four weeks.\n* Individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, IBS, IBD, SLE, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment.\n\nExclusion Criteria:\n\n* Individuals medically prescribed medications that would affect the immune and/or the inflammatory response.\n* Individuals deemed unsuitable for participation by Griffith CTU staff and/or the study clinician.\n* Active smokers/vapers and/or individuals with nicotine or drug habits.\n* Individuals currently participating in (or planning to participate in) other clinical trials.\n* Women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding.\n* Individuals unable to abstain from alcohol for two days prior to blood and urine sample collection.\n* Individuals unable to refrain from consuming other lactic acid bacteria supplements.\n* Individuals who are known to be HIV, HTLV-1, or HCV positive (based on answers to the enrolment questionnaire).'}, 'identificationModule': {'nctId': 'NCT06837961', 'briefTitle': 'LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'RDC Clinical Pty Ltd'}, 'officialTitle': 'The Effects of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Disease in Australian Healthy Adults. Randomized Placebo-controlled Double-blind Parallel Group Study.', 'orgStudyIdInfo': {'id': 'GU/2025/073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LC-Plasma', 'description': '1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks', 'interventionNames': ['Dietary Supplement: LC-Plasma']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'LC-Plasma', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks', 'armGroupLabels': ['LC-Plasma']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1 tablet containing 50mg MCC is taken daily for 4 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Griffith University', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}], 'overallOfficials': [{'name': 'Yusuke Ushida', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kirin Holdings Company, Limited'}, {'name': 'Osamu Kanauchi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kirin Holdings Company, Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RDC Clinical Pty Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kirin Holdings Company, Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}