CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Probiotic blenddietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06200935
NCT06200935N/ACompleted

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

Instituto de Genética Médica y Molecular·observational·Posted Jan 11, 2024·Updated Jan 11, 2024

In Brief

An observational study evaluating Probiotic blend for Neurodevelopmental Disorders. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 11, 2024
Enrollment StartOct 1, 2021
Primary CompletionAug 1, 2022
Study CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.5 years ago

Interventions

Probiotic blenddietary

Administration of one stick of combined probiotics per day for 5 months