An observational study in Neurodevelopmental Disorders, sponsored by Instituto de Genética Médica y Molecular. Completed at 1 site in Spain. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Instituto de Genética Médica y Molecular · Observational
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:
332 studies on the registry are indexed under Neurodevelopmental Disorders; 142 are open to participants now.
This study's enrollment of 90 is below the median of 200 across 124 observational studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →This is the only study on the registry with Instituto de Genética Médica y Molecular as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Dietary Supplement: Probiotic blend
Administration of one stick of combined probiotics per day for 5 months
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
Plan to share: Yes — Preparation of a scientific article
Supporting information: Study protocol
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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