Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02185092
Status:
WITHDRAWN
Last Update Posted:
2017-05-23
First Post:
2014-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Use in Patients With Prior COPD Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lost funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2014-07-03', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Systemic Steroid Use', 'timeFrame': '1 year', 'description': 'Decreased systemic steroid use'}], 'primaryOutcomes': [{'measure': 'COPD exacerbations', 'timeFrame': '1 year', 'description': 'The primary end point will be the number of COPD exacerbations.'}], 'secondaryOutcomes': [{'measure': 'Antibiotic Use', 'timeFrame': '1 year', 'description': 'Decreased oral or IV antibiotic use'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['exacerbations', 'COPD', 'pneumonia', 'probiotic'], 'conditions': ['COPD', 'Obstructive Lung Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with underlying COPD will be eligible and screened.\n2. Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows clinic at PPOB who have had a COPD exacerbation within the last year.\n3. Patients over age 18\n4. Patients who have a pulmonary function test (PFT) showing COPD within 1 year of enrollment in the study or if the treating physician plans to obtain PFT as part of the patient's care plan.\n5. Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD criteria).\n\nExclusion Criteria:\n\n1. Patients with less than one year of life expectancy from a concomitant diagnosis\n2. Any GI motility disorders or previous bowel resection surgery (short gut syndrome)\n3. Any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper).\n4. Patients admitted within the last one year with a diagnosis of pancreatitis\n5. Patients unable to give consent will not be included in the study.\n6. Patients unable to sign consent\n7. Patients already on azithromycin daily for COPD exacerbations\n8. Patients under department of corrections custody."}, 'identificationModule': {'nctId': 'NCT02185092', 'briefTitle': 'Probiotic Use in Patients With Prior COPD Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Probiotic Use in Patients With Prior COPD Exacerbation', 'orgStudyIdInfo': {'id': '4258'}, 'secondaryIdInfos': [{'id': 'RSRCH032089', 'type': 'OTHER', 'domain': 'OUHSC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': '1 pill orally daily', 'interventionNames': ['Other: Sugar pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lactobacillus GG', 'description': '1 pill (2 x 10x 9 CFU) daily orally', 'interventionNames': ['Dietary Supplement: Lactobacillus GG']}], 'interventions': [{'name': 'Lactobacillus GG', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Culturelle'], 'description': 'probiotic supplement', 'armGroupLabels': ['Lactobacillus GG']}, {'name': 'Sugar pill', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Sugar Pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OUHSC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Karen S Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}