Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:02 PM
Study NCT ID:
NCT06352203
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children with intestinal dysbiosis after 6 months of treatment.', 'timeFrame': 'After 6 months of intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodevelopmental Disorders']}, 'descriptionModule': {'briefSummary': 'Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.\n\nAn interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.\n\nThe duration of the study will be of 6 months approximately, including 6 months of product intake.\n\nParticipants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 3 to 7 years old.\n* Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.\n* Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).\n* Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.\n\nExclusion Criteria:\n\n* With intake of antibiotics in the last month.\n* With intake of probiotics in the last two weeks.\n* Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.\n* Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).\n* Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing\'s disease, Addison\'s disease, etc.\n* Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).\n* Congenital or acquired immunodeficiency.\n* Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).\n* Uncertainty on the part of the investigator about the willingness or ability of the minor\'s parents or legal guardian to comply with the requirements of the protocol.\n* With oral hyper sensitivity impairments that prevent the uptake of the study product.'}, 'identificationModule': {'nctId': 'NCT06352203', 'briefTitle': 'Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ProbiSearch SL'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.', 'orgStudyIdInfo': {'id': 'AUT/23.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 dose of the probiotic every 24 hours, for 6-months.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 dose of the placebo every 24 hours, for 6-months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Silvia Gutierrez, MD', 'role': 'CONTACT', 'email': 'susana.manzano@probisearch.com', 'phone': '+34918035179'}], 'facility': 'Hospital Universitario Infantil Niño Jesús', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Susana Manzano Jiménez, PhD', 'role': 'CONTACT', 'email': 'susana.manzano@probisearch.com', 'phone': '+34 918035179'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ProbiSearch SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}