Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning
Condition: Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Probiotic blend
Intervention type(s): Dietary Supplement
Intervention description(s): Administration of one stick of combined probiotics per day for 5 months
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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.
      
Keywords: Neurodevelopment; Probiotics; Microbiota; Learning; Children