Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-02 @ 12:06 AM
Study NCT ID:
NCT06990568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-23', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of antibiotic-associated diarrhea', 'timeFrame': 'Within 14 days after the cessation of Lacidofil or placebo administration', 'description': 'Antibiotic-Associated Diarrhea (Definition: Occurrence of diarrhea more than 3 times a day, occurring at least 24 hours after the first administration of antibiotics)\n\n\\* Diarrhea is defined using the Bristol Stool Form Scale (BSF) as BSF 6 or 7. BSF 6: Mushy stool \\[Soft pieces with ragged edges, mushy stool\\] BSF 7: Watery stool \\[Liquid-like, no solid form, completely liquid\\]'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Clostridium difficile infection', 'timeFrame': 'Within 14 days after the cessation of Lacidofil or placebo administration', 'description': 'Positive result in Clostridium difficile test: toxin, X-pert, or culture'}, {'measure': 'Total length of hospitalization', 'timeFrame': 'Within 14 days after the cessation of Lacidofil or placebo administration', 'description': 'the duration from admission to discharge'}, {'measure': 'Duration of antibiotic use', 'timeFrame': 'Within 14 days after the cessation of Lacidofil or placebo administration', 'description': 'period of antibiotic use during hospitalization + duration of oral antibiotic use after discharge'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia', 'Probiotics', 'Diarrhea']}, 'descriptionModule': {'briefSummary': 'The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 19 years or older admitted with a diagnosis of community-acquired pneumonia\n* Patients eligible for oral medication administration (able to take oral or enteral feeding)\n\nExclusion Criteria:\n\n* Sepsis patients\n* Patients admitted to the intensive care unit (ICU) following endotracheal intubation\n* Elderly patients aged 80 years or older\n* Pregnant women\n* Patients who have diarrhea at the time of admission\n* Patients with a history of using probiotics within 3 months prior to admission\n* Patients with a history of using laxatives within 1 week prior to admission\n* Patients suspected of being in shock (mean arterial pressure \\< 65 mmHg) at the time of admission'}, 'identificationModule': {'nctId': 'NCT06990568', 'acronym': 'PROBIO', 'briefTitle': 'Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'National Health Insurance Service Ilsan Hospital'}, 'officialTitle': 'The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': '2025-01-010'}, 'secondaryIdInfos': [{'id': 'NHIMC-2024-CR-070', 'type': 'OTHER_GRANT', 'domain': 'National Health Insurance Service Ilsan Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lacidofil', 'description': 'Take 1 capsule of Lacidofil in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days.', 'interventionNames': ['Drug: Lacidofil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Take 1 capsule of placebo in the morning and evening after meals, for a total of 2 times a day. The total duration of the dosage is the antibiotic treatment period plus 5 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lacidofil', 'type': 'DRUG', 'description': '1 capsule twice daily.', 'armGroupLabels': ['Lacidofil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 capsule twice daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eunki Chung, MD', 'role': 'CONTACT', 'email': 'ekchung@nhimc.or.kr', 'phone': '+82-31-900-3235'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Insurance Service Ilsan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Eunki Chung', 'investigatorAffiliation': 'National Health Insurance Service Ilsan Hospital'}}}}