Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-25 @ 2:54 PM
Study NCT ID:
NCT06205966
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-11', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-11', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)', 'timeFrame': '10 days'}, {'measure': 'Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".', 'timeFrame': '10 days', 'description': 'On a scale from 1 to 8.'}, {'measure': 'Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.', 'timeFrame': '10 days'}, {'measure': 'Amount of NSAIDs used.', 'timeFrame': '10 days'}, {'measure': 'Number of children receiving antibiotic treatment in each treatment group.', 'timeFrame': '10 days'}, {'measure': 'Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".', 'timeFrame': '10 days'}, {'measure': 'Number of unplanned medical visits (other than "Visit 1 and 2").', 'timeFrame': '10 days', 'description': 'This outcome is defined as the total amount of medical office visits or emergency visits.'}, {'measure': 'Days of absences from day care center/school.', 'timeFrame': '10 days', 'description': 'This outcome is defined as the total amount of days of absences from the day care centre during the study, due to the presence of episodes of URTI.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virus Diseases in Children']}, 'referencesModule': {'references': [{'pmid': '33789556', 'type': 'BACKGROUND', 'citation': 'Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.', 'detailedDescription': "Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)\n* Any gender\n* Age from 4 years to 17 years\n* Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years\n* Negative Strep test\n\nExclusion Criteria:\n\n* Use of antibiotics or probiotics in the 10 days prior to study enrolment\n* Use of a probiotic other than the test sample during the study\n* Eight or more otitis media within 12 months\n* Two or more bacterial sinusitis within 12 months\n* Two or more pneumonia episodes within 12 months\n* History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)\n* Chronic diarrhea\n* Recurrent deep skin or organ abscesses\n* Persistent superficial candidiasis\n* Use of antibiotics for two months or more to treat respiratory infections within 12 months\n* Gastroesophageal reflux\n* Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy\n* Primary or secondary ciliary dyskinesia\n* Congenital malformations of the respiratory tract'}, 'identificationModule': {'nctId': 'NCT06205966', 'briefTitle': 'A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children', 'organization': {'class': 'OTHER', 'fullName': 'Szent Miklós Szolgálat Kft.'}, 'officialTitle': 'A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children', 'orgStudyIdInfo': {'id': 'SzentMiklósSzolgálatKft.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'description': 'Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops.', 'interventionNames': ['Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo taken orally once in the morning and once in the evening, each time 5 drops.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2310', 'city': 'Szigetszentmiklós', 'state': 'Pest County', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Gergely Milosevits, M.D., PhD.', 'role': 'CONTACT', 'email': 'drgergelymilosevits@gmail.com', 'phone': '+36308425722'}, {'name': 'Gergely Milosevits, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Szent Miklós Szolgálat Kft.', 'geoPoint': {'lat': 47.34382, 'lon': 19.04335}}], 'centralContacts': [{'name': 'Gergely Milosevits, MD, PhD', 'role': 'CONTACT', 'email': 'drgergelymilosevits@gmail.com', 'phone': '+36308425722'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milosevits Gergely', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Milosevits Gergely', 'investigatorAffiliation': 'Szent Miklós Szolgálat Kft.'}}}}