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| Name | Class |
|---|---|
| Industrial Farmacéutica Cantabria, S.A. | INDUSTRY |
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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.
The 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.
The trial was conducted in 4 stages:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with neurodevelopmental disorders | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic blend | Dietary Supplement | Administration of one stick of combined probiotics per day for 5 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota | Examination of fecal samples | Through study completion, an average of 6 months |
| Intestinal permeability | Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Analyze improvement in language, behavior and learning | By monitoring at the school, asking family members and with a face-to-face visit by the doctor. SENA behavioral test is performed at the end of the study | Through study completion, an average of 6 months |
| Analyze the outcome in pre-existing digestive disorders |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Lapunzina | Instituto de Genética Médica y Molecular (INGEMM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MencÃa Hermosa Vicente | Madrid | 28043 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28028357 | Result | 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. | |
| 31035684 | Result | 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. |
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Preparation of a scientific article
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A complete medical history and a survey |
| Through study completion, an average of 6 months |
| Analyze the composition of the microbiota and its improvement | By collecting fecal samples | Through study completion, an average of 6 months |
| 24777214 | Result | 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. |
| 32635373 | Result | 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. |
| 28222761 | Result | 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. |
| 31982866 | Result | 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. |
| 26306709 | Result | 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. |
| 27199937 | Result | 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. |
| 28123052 | Result | 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. |
| 31739175 | Result | 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. |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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