Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 3:35 AM
Study NCT ID:
NCT06885632
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-13', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the structure of fecal microbiota before and after the intervention.', 'timeFrame': 'Week 0 and Week 8', 'description': 'Analyzed by 16S rRNA sequencing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children With Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of probiotic gummies on serum metabolite levels, clinical efficacy, and regulation of gut microbiota in children with allergic rhinitis compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntary, written, signed informed consent to participate in this study;\n2. be able to complete the study in accordance with the requirements of the test protocol;\n3. Age 4-14 years old;\n4. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);\n5. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;\n6. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;\n\nExclusion Criteria:\n\n1. Drugs that affect the intestinal flora (including antimicrobial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening;\n2. Patients with pulmonary tuberculosis;\n3. Combined with allergic asthma;\n4. Those with nasal polyps or severe nasal septum deviation;\n5. Patients with severe systemic diseases or malignant tumors;\n6. Those with congenital genetic diseases and congenital immunodeficiency diseases;\n7. Those who regularly use probiotics or prebiotics within 6 months before the screening period;\n8. Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);\n9. Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);\n10. Patients with sinusitis, otitis media, or respiratory tract infection;\n11. Those who are allergic to the probiotic-related ingredients used in this trial;\n12. Those who stop taking the test sample or add other drugs in the middle of the test, and the efficacy cannot be judged or the data is incomplete;\n13. Those who take items with similar functions to the test in a short period of time, which affects the judgment of the results;\n14. Subjects who are unable to participate in the test due to their own reasons;\n15. Subjects who are judged by other investigators to be insuitable to participate.'}, 'identificationModule': {'nctId': 'NCT06885632', 'briefTitle': 'Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'The Effectiveness of Probiotic Gummies in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile', 'orgStudyIdInfo': {'id': 'WK20250314'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'Probiotic pectin gummies(500 million CFU)/2 pellets/day BC99', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'No probiotic pectin gummies/2 pellets/day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study lasts 56 days and each patient will have 3 visits (week0, week4, week8).', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '471000', 'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Wu, doctor', 'role': 'CONTACT', 'email': 'wuying2000@126.com', 'phone': '18639283502', 'phoneExt': '+86'}], 'facility': 'The School of Food and Bioengineering, Henan University of Science and Technolog', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}