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Completed

NCT Number: 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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mencía Hermosa Vicente

Madrid, 28043, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Blend

Dietary Supplement

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

Primary outcomes

  1. Microbiota

    Time frame: Through study completion, an average of 6 months

    Examination of fecal samples

  2. Intestinal permeability

    Time frame: Through study completion, an average of 6 months

    Examination of fecal samples and a complete medical history and a survey aimed mainly at ruling out digestive symptoms

Secondary outcomes

  1. Analyze improvement in language, behavior and learning

    Time frame: Through study completion, an average of 6 months

    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

  2. Analyze the outcome in pre-existing digestive disorders

    Time frame: Through study completion, an average of 6 months

    A complete medical history and a survey

  3. Analyze the composition of the microbiota and its improvement

    Time frame: Through study completion, an average of 6 months

    By collecting fecal samples

Sponsors and collaborators

Lead sponsor

Instituto de Genética Médica y Molecular

Network

Collaborators

  • Industrial Farmacéutica Cantabria, S.A.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2024
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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