Neurodevelopmental Disorders
Conditions
Keywords
Neurodevelopment, Probiotics, Microbiota, Learning, Children
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotic blend
Administration of one stick of combined probiotics per day for 5 months
Sponsors
Industrial Farmacéutica Cantabria, S.A.
Instituto de Genética Médica y Molecular
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children with neurodevelopmental disorders between 3 and 16 years old * Similar characteristics in terms of type of food
Exclusion criteria
* Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota | Through study completion, an average of 6 months | Examination of fecal samples |
| Intestinal permeability | Through study completion, an average of 6 months | Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analyze improvement in language, behavior and learning | Through study completion, an average of 6 months | 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 |
| Analyze the outcome in pre-existing digestive disorders | Through study completion, an average of 6 months | A complete medical history and a survey |
| Analyze the composition of the microbiota and its improvement | Through study completion, an average of 6 months | By collecting fecal samples |
Countries
Spain
Outcome results
None listed