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Action of Probiotics on the Microbiota and Intestinal Permeability in Children With Neurodevelopmental Disorders and Their Influence on the Improvement of Language and Learning

NCT06200935 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-01-11

No results posted yet for this study

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.

Conditions

  • Neurodevelopmental Disorders

Interventions

DIETARY_SUPPLEMENT

Probiotic blend

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

Sponsors & Collaborators

  • Industrial Farmacéutica Cantabria, S.A.

    collaborator INDUSTRY

  • Instituto de Genética Médica y Molecular

    lead NETWORK

Principal Investigators

  • Pablo Lapunzina · Instituto de Genética Médica y Molecular (INGEMM)

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-08-01
Completion
2022-10-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06200935 on ClinicalTrials.gov