Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-20 @ 6:52 PM
Study NCT ID:
NCT01782118
Status:
UNKNOWN
Last Update Posted:
2013-10-31
First Post:
2013-01-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LGG for Prevention of Infectious Complications During PPI Treatment in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2013-01-21', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2013-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'serum level of 25OHD', 'timeFrame': 'at 6 weeks'}, {'measure': 'serum level of ferritin', 'timeFrame': 'at 6 weeks'}, {'measure': 'Total iron binding capacity', 'timeFrame': 'at 6 weeks'}, {'measure': 'serum level of ferrum', 'timeFrame': 'at 6 weeks'}, {'measure': 'fecal calprotectin', 'timeFrame': 'at 6 weeks'}], 'primaryOutcomes': [{'measure': 'Respiratory tract infections', 'timeFrame': 'up to 3 months after termination of intervention', 'description': 'Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention'}, {'measure': 'Gastrointestinal tract infections', 'timeFrame': 'up to 3 months after termination of intervention', 'description': 'Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention'}], 'secondaryOutcomes': [{'measure': 'Number of pneumonias', 'timeFrame': 'up to 3 months after termination of intervention', 'description': 'during intervention plus 3 months after termination of the intervention'}, {'measure': 'Adverse events', 'timeFrame': 'up to 3 months after termination of intervention', 'description': 'Number and character of adverse events during intervention plus 3 months after termination of the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease', 'Gastrointestinal Infections', 'Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.\n\nAim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.\n\nStudy design: Randomized, double-blind, placebo controlled trial.', 'detailedDescription': 'Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\<5,\n* clinical symptoms of GERD\n* treatment with proton pump inhibitors\n* signed informed consent\n\nExclusion Criteria:\n\n* treatment with PPI within the last 4 weeks for at least 2 weeks\n* administration of probiotics within 7 days prior to the study\n* acute or chronic respiratory tract infections\n* acute or chronic gastrointestinal tract infections\n* neurological disorders\n* immunodeficiency'}, 'identificationModule': {'nctId': 'NCT01782118', 'briefTitle': 'LGG for Prevention of Infectious Complications During PPI Treatment in Children', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.', 'orgStudyIdInfo': {'id': '1/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus GG', 'description': 'Lactobacillus GG given for six weeks two times per day.', 'interventionNames': ['Dietary Supplement: Lactobacillus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo two times per day for six weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus GG']}], 'interventions': [{'name': 'Lactobacillus GG', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dicoflor'], 'armGroupLabels': ['Lactobacillus GG', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Katarzyna Krenlke, MD', 'role': 'CONTACT', 'email': 'katarzynakrenke@gmail.com', 'phone': '+48224523204'}, {'name': 'Piotr Dziechciarz, MD', 'role': 'CONTACT', 'phone': '+48224523292'}, {'name': 'Katarzyna Krenke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Piotr Dziechciarz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hania Szajewska, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andrea Horvath, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Katarzyna Krenke, MD', 'role': 'CONTACT', 'email': 'katarzynakrenke@gmail.com', 'phone': '+48224523204'}, {'name': 'Piotr Dziechciarz, MD', 'role': 'CONTACT', 'email': 'piotrdz@hotmail.com', 'phone': '+48224523292'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hanna Szajewska', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}