Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-01 @ 2:04 PM
Study NCT ID:
NCT06348095
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011019', 'term': 'Pneumonia, Mycoplasma'}], 'ancestors': [{'id': 'D009175', 'term': 'Mycoplasma Infections'}, {'id': 'D009180', 'term': 'Mycoplasmatales Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mycoplasma pneumoniae load', 'timeFrame': '7天', 'description': 'Mycoplasma pneumoniae load was detected by tNGS'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mycoplasma Pneumoniae Pneumonia']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae pneumonia, in comparison with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet the diagnostic criteria for pneumonia in "Zhufutang Practical Pediatrics" (7th Edition), and is diagnosed with Mycoplasma pneumoniae pneumonia using tNGS technology;\n2. Infants and young children aged 6 months to 3 years;\n3. The course of the disease is \\<48 h;\n4. The family members of the children are informed about the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Previous history of wheezing;\n2. Cardiovascular disease and congenital tracheal dysplasia;\n3. pneumonia induced by other causes;\n4. Dysplasia of bronchial and pulmonary tracts;\n5. premature infants;\n6. Combined with immunosuppressive diseases;\n7. Presence of mental illness.'}, 'identificationModule': {'nctId': 'NCT06348095', 'briefTitle': 'Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wecare Probiotics Co., Ltd.'}, 'officialTitle': 'Effect of Probiotic WecProB on the Course of Mycoplasma Pneumoniae Pneumonia in Children', 'orgStudyIdInfo': {'id': 'WK2024004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics group', 'description': '2B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Maltodextrin, one strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).', 'armGroupLabels': ['Probiotics group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).', 'armGroupLabels': ['Placebo group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wecare Probiotics Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}