Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT06200935
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2023-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiota', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Examination of fecal samples'}, {'measure': 'Intestinal permeability', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms'}], 'secondaryOutcomes': [{'measure': 'Analyze improvement in language, behavior and learning', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'By monitoring at the school, asking family members and with a face-to-face visit by the doctor.\n\nSENA behavioral test is performed at the end of the study'}, {'measure': 'Analyze the outcome in pre-existing digestive disorders', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'A complete medical history and a survey'}, {'measure': 'Analyze the composition of the microbiota and its improvement', 'timeFrame': 'Through study completion, an average of 6 months', 'description': 'By collecting fecal samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurodevelopment', 'Probiotics', 'Microbiota', 'Learning', 'Children'], 'conditions': ['Neurodevelopmental Disorders']}, 'referencesModule': {'references': [{'pmid': '28028357', 'type': 'RESULT', 'citation': 'Navarro F, Liu Y, Rhoads JM. Can probiotics benefit children with autism spectrum disorders? World J Gastroenterol. 2016 Dec 14;22(46):10093-10102. doi: 10.3748/wjg.v22.i46.10093.'}, {'pmid': '31035684', 'type': 'RESULT', 'citation': 'Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.'}, {'pmid': '24777214', 'type': 'RESULT', 'citation': 'McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.'}, {'pmid': '32635373', 'type': 'RESULT', 'citation': 'Johnson D, Letchumanan V, Thurairajasingam S, Lee LH. A Revolutionizing Approach to Autism Spectrum Disorder Using the Microbiome. Nutrients. 2020 Jul 3;12(7):1983. doi: 10.3390/nu12071983.'}, {'pmid': '28222761', 'type': 'RESULT', 'citation': 'Strati F, Cavalieri D, Albanese D, De Felice C, Donati C, Hayek J, Jousson O, Leoncini S, Renzi D, Calabro A, De Filippo C. New evidences on the altered gut microbiota in autism spectrum disorders. Microbiome. 2017 Feb 22;5(1):24. doi: 10.1186/s40168-017-0242-1.'}, {'pmid': '31982866', 'type': 'RESULT', 'citation': 'Bezawada N, Phang TH, Hold GL, Hansen R. Autism Spectrum Disorder and the Gut Microbiota in Children: A Systematic Review. Ann Nutr Metab. 2020;76(1):16-29. doi: 10.1159/000505363. Epub 2020 Jan 24.'}, {'pmid': '26306709', 'type': 'RESULT', 'citation': 'Liu X, Cao S, Zhang X. Modulation of Gut Microbiota-Brain Axis by Probiotics, Prebiotics, and Diet. J Agric Food Chem. 2015 Sep 16;63(36):7885-95. doi: 10.1021/acs.jafc.5b02404. Epub 2015 Sep 1.'}, {'pmid': '27199937', 'type': 'RESULT', 'citation': 'Martin R, Laval L, Chain F, Miquel S, Natividad J, Cherbuy C, Sokol H, Verdu EF, van Hylckama Vlieg J, Bermudez-Humaran LG, Smokvina T, Langella P. Bifidobacterium animalis ssp. lactis CNCM-I2494 Restores Gut Barrier Permeability in Chronically Low-Grade Inflamed Mice. Front Microbiol. 2016 May 6;7:608. doi: 10.3389/fmicb.2016.00608. eCollection 2016.'}, {'pmid': '28123052', 'type': 'RESULT', 'citation': 'Hughes KR, Harnisch LC, Alcon-Giner C, Mitra S, Wright CJ, Ketskemety J, van Sinderen D, Watson AJ, Hall LJ. Bifidobacterium breve reduces apoptotic epithelial cell shedding in an exopolysaccharide and MyD88-dependent manner. Open Biol. 2017 Jan;7(1):160155. doi: 10.1098/rsob.160155.'}, {'pmid': '31739175', 'type': 'RESULT', 'citation': 'Fornai M, Pellegrini C, Benvenuti L, Tirotta E, Gentile D, Natale G, Ryskalin L, Colucci R, Piccoli E, Ghelardi E, Blandizzi C, Antonioli L. Protective effects of the combination Bifidobacterium longum plus lactoferrin against NSAID-induced enteropathy. Nutrition. 2020 Feb;70:110583. doi: 10.1016/j.nut.2019.110583. Epub 2019 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'The study included boys and girls with neurodevelopmental disorders between the ages of 3 and 16 years, belonging to two educational centers in Madrid, attended by children with this type of disorder. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them. The study will be randomized, so that probiotics will be administered to some children and placebos to others; and blinded, so that neither the patient nor his family will know whether probiotic or placebo is administered.\n\nThe aim of this project is to study the results obtained on microbiota, intestinal permeability, language, behavior and learning of a probiotic combination that will be administered to children in several educational centers that care for children with neurodevelopmental disorders for 5 months.', 'detailedDescription': 'The trial was conducted in 4 stages:\n\n* Probiotic development, which will be randomized, so that some children will receive the probiotic and others placebos, and blinded, so that neither the children nor their relatives will know whether they take placebo or probiotic.\n* Initial survey to rule out digestive symptoms and resolve possible doubts. Data will be collected on type of housing, location, number of family members, and others. Collection of fecal samples prior to the administration of the probiotic, to carry out a microbiota and intestinal permeability study.\n* Administration of the probiotic preparation or placebo to the subjects for 5 months. Monitoring will be done within each center and in the middle of the treatment the doctors will make a face-to-face visit to see the children.\n* In the last phase a new online visit is made where a complete clinical history and a survey to rule out digestive symptomatology are evaluated. A neurocognitive evaluation is also done using the SENA behavioral test. New fecal samples are collected for a microbiota and intestinal permeability study following the same procedure as in the second stage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Boys and girls with neurodevelopmental disorders between 3 and 16 years of age, belonging to two educational centers in Madrid, which are attended by children with this type of disorders. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with neurodevelopmental disorders between 3 and 16 years old\n* Similar characteristics in terms of type of food\n\nExclusion Criteria:\n\n* Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation'}, 'identificationModule': {'nctId': 'NCT06200935', 'briefTitle': 'Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning', 'organization': {'class': 'NETWORK', 'fullName': 'Instituto de Genética Médica y Molecular'}, 'officialTitle': 'Results of the Action of a Combination of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language, Behavioral Evolution and Learning', 'orgStudyIdInfo': {'id': 'MICROBIOTA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with neurodevelopmental disorders', 'description': 'Boys and girls with neurodevelopmental disorders between 3 and 16 years of age, belonging to two educational centers in Madrid, attended by children with this type of disorders. Both centers have similar characteristics in terms of the type of feeding and management of the children attending them', 'interventionNames': ['Dietary Supplement: Probiotic blend']}], 'interventions': [{'name': 'Probiotic blend', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of one stick of combined probiotics per day for 5 months', 'armGroupLabels': ['Children with neurodevelopmental disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28043', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Mencía Hermosa Vicente', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Pablo Lapunzina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto de Genética Médica y Molecular (INGEMM)'}]}, 'ipdSharingStatementModule': {'url': 'https://www.fundacionquerer.org/resultado-de-la-accion-de-una-combinacion-de-probioticos/', 'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'Preparation of a scientific article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Genética Médica y Molecular', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Industrial Farmacéutica Cantabria, S.A.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}