Clinical trial NCT06200935: Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning
Official title: Results of the Action of a Combination of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language, Behavioral Evolution and Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurodevelopmental Disorders
Keywords: Neurodevelopment
Probiotics
Microbiota
Learning
Children
Lead sponsor: Instituto de Genética Médica y Molecular
Sponsor class: NETWORK
Collaborators: name: Industrial Farmacéutica Cantabria, S.A.
First posted: 2024-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiota
timeFrame: Through study completion, an average of 6 months
measure: Intestinal permeability
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Analyze improvement in language, behavior and learning
timeFrame: Through study completion, an average of 6 months
measure: Analyze the outcome in pre-existing digestive disorders
timeFrame: Through study completion, an average of 6 months
measure: Analyze the composition of the microbiota and its improvement
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Mencía Hermosa Vicente
Study officials:
affiliation: Instituto de Genética Médica y Molecular (INGEMM)
name: Pablo Lapunzina
role: PRINCIPAL_INVESTIGATOR
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