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: * 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. * 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. * 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. * 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.
Study Type
OBSERVATIONAL
Enrollment
90
Administration of one stick of combined probiotics per day for 5 months
Mencía Hermosa Vicente
Madrid, Spain
Microbiota
Examination of fecal samples
Time frame: 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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
Analyze the outcome in pre-existing digestive disorders
A complete medical history and a survey
Time frame: Through study completion, an average of 6 months
Analyze the composition of the microbiota and its improvement
By collecting fecal samples
Time frame: Through study completion, an average of 6 months
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