Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT07114133
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-11
First Post:
2025-07-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the TNSS score at 3 Months', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cat Allergy', 'Allergic Rhinitis', 'Allergic Asthma', 'Environmental Probiotics'], 'conditions': ['Cat Allergy (Disorder)', 'Allergic Rhinitis', 'Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'Objective of this clinical trial:\n\nThe goal of this clinical study is to evaluate whether an environmental probiotic spray can improve symptoms in adults with cat allergy-induced allergic rhinitis (AR) and allergic asthma (AA). It will also assess the safety of the probiotic spray. The main questions it aims to answer are:\n\nDoes the environmental probiotic spray reduce the severity of nasal and asthma symptoms in participants? Are there any adverse effects observed in participants using the probiotic spray? Researchers will compare the environmental probiotic spray group to a placebo group (a look-alike spray containing no active ingredients) to determine if the probiotic spray is effective in managing allergic rhinitis and asthma symptoms.\n\nParticipants will:\n\nReceive the environmental probiotic spray or placebo daily for 3 months Attend monthly clinic visits for checkups and assessments Undergo a final evaluation at 3 months, including symptom scoring and safety checks\n\nKey Assessments:\n\nTotal Nasal Symptom Score (TNSS) for allergic rhinitis Asthma Control Test (ACT) score for allergic asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-70 years；\n* Diagnosed with cat allergy (cat dander-specific IgE level ≥ class 2: \\> 0.7 IU/mL) and allergic rhinitis with or without allergic asthma;\n* Residing in the same living environment for at least 3 months (and no plans to change residence within the next 6 months);\n* Patients receiving conventional symptomatic treatment.\n\nExclusion Criteria:\n\n* Presence of other severe systemic diseases;\n* Residence duration \\< 3 months or plans to change residence within the next 6 months;\n* Pregnancy;\n* Current or planned use of biologic therapy;\n* Any other condition that, in the investigator's judgment, may pose significant risks to the participant if enrolled in the study."}, 'identificationModule': {'nctId': 'NCT07114133', 'briefTitle': 'A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies', 'orgStudyIdInfo': {'id': '2025-0723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Environmental Probiotic Spray Intervention Arm', 'description': 'Participants in this arm will administer the environmental probiotic spray at home according to the following protocol:\n\nFirst bottle: 3 times daily (TID), 30 actuations per administration Subsequent bottles (from second bottle onward): Once daily (QD), 15 actuations per administration Total duration: 3 months', 'interventionNames': ['Other: Environmental Probiotic Spray Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Purified Water Spray Intervention Arm', 'description': 'Participants in this arm will administer the purified water spray at home according to the following protocol:\n\nFirst bottle: 3 times daily (TID), 30 actuations per administration Subsequent bottles (from second bottle onward): Once daily (QD), 15 actuations per administration Total duration: 3 months', 'interventionNames': ['Other: Purified water spray (containing no active ingredients) as the placebo control']}], 'interventions': [{'name': 'Environmental Probiotic Spray Intervention', 'type': 'OTHER', 'description': 'The probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J', 'armGroupLabels': ['Environmental Probiotic Spray Intervention Arm']}, {'name': 'Purified water spray (containing no active ingredients) as the placebo control', 'type': 'OTHER', 'description': 'Purified water spray', 'armGroupLabels': ['Purified Water Spray Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}