Clinical Trials Logo
  1. Home
  2. Neurodevelopmental Disorders
  3. 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

Neurodevelopmental Disorders Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06200935
Study type Observational
Source Instituto de Genética Médica y Molecular
Contact
Status Completed
Phase
Start date October 1, 2021
Completion date October 1, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT03148782 - Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase N/A
Active, not recruiting NCT04935593 - Strengthening Social, Emotional and Behavioral Resilience N/A
Recruiting NCT03222375 - SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Completed NCT04313283 - Translating Peer-to-Peer Support Into a Clinical Setting N/A
Completed NCT04562935 - Long-term Consequences of Admission for Pediatric Intensive Care Before One Year of Age
Not yet recruiting NCT05815095 - Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services
Recruiting NCT05017363 - Evaluation of the Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach) N/A
Completed NCT06251830 - Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?
Completed NCT06052878 - Neurodevelopmental Outcome After Prenatal Anesthesia
Recruiting NCT06012903 - Lower Urinary Tract Symptoms and School Functioning in Children
Not yet recruiting NCT05490173 - The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants N/A
Not yet recruiting NCT06081348 - Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders Phase 2
Not yet recruiting NCT05564871 - Effectiveness of Occupational Therapy Teleintervention in Pediatric N/A
Enrolling by invitation NCT02871674 - Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial N/A
Completed NCT01922791 - Nutrition and Pregnancy Intervention Study N/A
Active, not recruiting NCT05428657 - EC Brain Program for Children With Special Education Needs N/A
Recruiting NCT06111898 - Neuro-biomechanical Determinants for Motor Behavior in High-risk Infants
Recruiting NCT05658965 - KIDSHEART AND BRAIN : Early EEG Surgery Congenital Heart Disease Predict Onset of Neurodevelopmental Disorders
Recruiting NCT05997680 - A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study N/A
Recruiting NCT06057441 - Auditory and Visual Noise as Possible Non-pharmacological Treatment of ADHD in School Children N/A