Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06403358
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study for Evaluation of Probiotics in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2024-04-19', 'studyFirstSubmitQcDate': '2024-05-03', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea', 'timeFrame': 'Baseline, during the intervention, immediately after the intervention', 'description': 'Reduction of the number of loose stools per day'}, {'measure': 'Evaluation of the efficacy of oral administration of probiotics food supplement in paediatric population with acute diarrhea', 'timeFrame': 'Baseline, during the intervention, immediately after the intervention', 'description': 'Reduction of diarrhea duration.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the safety profile of probiotics food supplement', 'timeFrame': 'Immediately after the intervention', 'description': 'Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit.'}, {'measure': 'Evaluation of the safety profile of probiotics food supplement', 'timeFrame': 'During the intervention, immediately after the intervention', 'description': 'Evaluation of the eventual presence adverse event/serious adverse events.'}, {'measure': 'Assessment of the compliance to the treatment', 'timeFrame': 'During the intervention, immediately after the intervention', 'description': 'Compilation of the daily diary to the family;Compilation of the degree satisfaction questionnaires to the family;Compilation of the degree satisfaction questionnaires to the patient'}, {'measure': 'Analysis of the hydration state', 'timeFrame': 'BaselinaDuring the intervention, immediately after the intervention', 'description': 'Degree of dehydration using the Gorelick scale: using the 10-point score: 0 to 3 (mild dehydration), 3 to 5 (moderate dehydration), 6 to 10 (severe dehydration); Change in body weight;'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety and hydration index about the oral administration of probiotics food supplement in the re-equilibration of the intestinal microbiota, in presence of acute diarrhea', 'detailedDescription': 'Multicenter, observational prospective study evaluating the efficacy, safety and index of hydration resulting from oral administration of probiotics food supplement in paediatric age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* • Male and female patients aged between 3 and 14 years;\n\n * Patients with one of the following conditions:\n\n * Population with acute diarrhea;\n * Occurrence of at list three liquid or loose stools per day;\n * Consistency of stools (≥ type 5) according to Bristol Stool Scale Form (BFS).\n * Informed consent signed by parents or the patient's legal guardian(s) for study enrollment.\n\nExclusion Criteria:\n\n* • Presence of chronic diarrhea characterized by the emission of poorly formed stools, for more than 4 weeks, accompanied by increased frequency of evacuation or urgency to defecation;\n\n * Known or potential hypersensitivity and/or history of allergic reactions to one of the components of probiotics food supplement;\n * Coexisting severe infection (e.g. sepsis, pneumonia, meningitis);\n * Patients affected by chronic intestinal disease, immune deficiency, neurological disease and tumors;\n * Contemporary consumption of other probiotics compounds;\n * Patients whose parents or the patient's legal guardian(s)refuse to provide written informed consent;\n * Patient who has not expressed his consent according to his age and level of understanding;\n * Participation in another clinical trial within the previous 30 days;\n * Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the investigator does not allow the participation in the study or could compromise the results"}, 'identificationModule': {'nctId': 'NCT06403358', 'briefTitle': 'Study for Evaluation of Probiotics in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Labomar SPA'}, 'officialTitle': 'Prospective Observational Study for the Evaluation of Probiotics Food Supplement in the Re-equilibration of the Intestinal Microbiota, in Paediatric Age', 'orgStudyIdInfo': {'id': 'YOV/042022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'YOVIS BIMBI', 'type': 'DIETARY_SUPPLEMENT', 'description': '42 male and female subjects, aged between 3 and 14 years with acute diarrhea will be treated with Yovis BAMBINI. The 42 subjects will be recruited with a competitive enrolment at the involved study sites.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95030', 'city': 'Gravina di Catania', 'state': 'Catania', 'country': 'Italy', 'facility': 'Studio Pediatrico Dr. Gaetano Bottaro', 'geoPoint': {'lat': 37.56085, 'lon': 15.06292}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Labomar SPA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}