Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 1:29 AM
Study NCT ID:
NCT01201434
Status:
TERMINATED
Last Update Posted:
2014-07-22
First Post:
2010-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Severe allergic reaction in one patient', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-21', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of probiotics on the rate of pulmonary infections compared to placebo', 'timeFrame': 'October 2012', 'description': 'The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.'}], 'secondaryOutcomes': [{'measure': 'The effect of probiotics on sputum bacteria compared to placebo', 'timeFrame': 'October 2012'}, {'measure': 'The effect of probiotics on sputum inflammatory markers', 'timeFrame': 'October 2012'}, {'measure': 'The effect of probiotics on gastrointestinal inflammation', 'timeFrame': 'October 2012'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'probiotics', 'pulmonary', 'infections'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '20503277', 'type': 'BACKGROUND', 'citation': 'Weiss B, Bujanover Y, Yahav Y, Vilozni D, Fireman E, Efrati O. Probiotic supplementation affects pulmonary exacerbations in patients with cystic fibrosis: a pilot study. Pediatr Pulmonol. 2010 Jun;45(6):536-40. doi: 10.1002/ppul.21138.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.', 'detailedDescription': 'Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cystic fibrosis mild to moderate\n* at least 3 pulmonary exacerbations requiring antibiotics per year\n* Pseudomonas aeruginosa in the sputum\n* able to produce sputum\n\nExclusion Criteria:\n\n* severe pulmonary disease\n* less than 3 pulmonary exacerbations per year\n* unable to produce sputum'}, 'identificationModule': {'nctId': 'NCT01201434', 'briefTitle': 'Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'SHEBA-10-7702-BW-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics, Treatment, Food Additive', 'interventionNames': ['Dietary Supplement: Bio-25 probiotic']}], 'interventions': [{'name': 'Bio-25 probiotic', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Bio-25 by Supherb'], 'description': '2 tablets per day for 6 months', 'armGroupLabels': ['Probiotics, Treatment, Food Additive']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Batia Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center"}, {'name': 'Ori Efrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Pulmonology Unit, Edmond and Lily safra Children's Hospital, Sheba Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director, Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital", 'investigatorFullName': 'Batia Weiss', 'investigatorAffiliation': 'Sheba Medical Center'}}}}