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Neurodevelopmental DisordersNCT06200935

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

An observational study of Neurodevelopmental Disorders, run by Instituto de Genética Médica y Molecular at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 3 to 16 years
Conditions the study is for
Neurodevelopmental Disorders
What is being tested?
Probiotic blend
How many people
90 participants
Where
1 siteSpain
Study dates
1 Oct 2021to 1 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

  • Children with neurodevelopmental disorders between 3 and 16 years old
  • Similar characteristics in terms of type of food

Who cannot join

  • Digestive symptomatology: gastroesophageal reflux, abdominal pain, flatulence, dysphagia, abdominal distension or constipation

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Mencía Hermosa Vicente

    Madrid, 28043

Other trials in Spain

About this study

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

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.

Read the 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.
Being tested
Probiotic blend
Keywords
Neurodevelopment, Probiotics, Microbiota, Learning, Children
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic blendDietary supplement

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

Study groups in NCT06200935
Study groupRoleWhat they receive
Children with neurodevelopmental disordersBoys and girls with neurodevelopmental disorders between 3 and 16 years of age, belonging to two educational centers in Madrid, 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
Receives: Dietary Supplement: Probiotic blend

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbiota

    Examination of fecal samples

    Measured: Through study completion, an average of 6 months

  2. Intestinal permeability

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

    Measured: Through study completion, an average of 6 months

Secondary outcomes (3)

  1. Analyze improvement in language, behavior and learning

    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

    Measured: Through study completion, an average of 6 months

  2. Analyze the outcome in pre-existing digestive disorders

    A complete medical history and a survey

    Measured: Through study completion, an average of 6 months

  3. Analyze the composition of the microbiota and its improvement

    By collecting fecal samples

    Measured: Through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2024
  2. Study start1 Oct 2021
  3. Primary completion1 Aug 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200935
Sponsor's protocol ID
MICROBIOTA
Status last verified
Jan 2024
First submitted
5 Dec 2023
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Preparation of a scientific article

Publications

  • Navarro F, Liu Y, Rhoads JM. Can probiotics benefit children with autism spectrum disorders? World J Gastroenterol. 2016 Dec 14;22(46):10093-10102. doi: 10.3748/wjg.v22.i46.10093.

    PubMed 28028357

  • Srikantha P, Mohajeri MH. The Possible Role of the Microbiota-Gut-Brain-Axis in Autism Spectrum Disorder. Int J Mol Sci. 2019 Apr 29;20(9):2115. doi: 10.3390/ijms20092115.

    PubMed 31035684

  • McElhanon BO, McCracken C, Karpen S, Sharp WG. Gastrointestinal symptoms in autism spectrum disorder: a meta-analysis. Pediatrics. 2014 May;133(5):872-83. doi: 10.1542/peds.2013-3995.

    PubMed 24777214

  • Johnson D, Letchumanan V, Thurairajasingam S, Lee LH. A Revolutionizing Approach to Autism Spectrum Disorder Using the Microbiome. Nutrients. 2020 Jul 3;12(7):1983. doi: 10.3390/nu12071983.

    PubMed 32635373

  • Strati F, Cavalieri D, Albanese D, De Felice C, Donati C, Hayek J, Jousson O, Leoncini S, Renzi D, Calabro A, De Filippo C. New evidences on the altered gut microbiota in autism spectrum disorders. Microbiome. 2017 Feb 22;5(1):24. doi: 10.1186/s40168-017-0242-1.

    PubMed 28222761

  • Bezawada N, Phang TH, Hold GL, Hansen R. Autism Spectrum Disorder and the Gut Microbiota in Children: A Systematic Review. Ann Nutr Metab. 2020;76(1):16-29. doi: 10.1159/000505363. Epub 2020 Jan 24.

    PubMed 31982866

  • Liu X, Cao S, Zhang X. Modulation of Gut Microbiota-Brain Axis by Probiotics, Prebiotics, and Diet. J Agric Food Chem. 2015 Sep 16;63(36):7885-95. doi: 10.1021/acs.jafc.5b02404. Epub 2015 Sep 1.

    PubMed 26306709

  • Martin R, Laval L, Chain F, Miquel S, Natividad J, Cherbuy C, Sokol H, Verdu EF, van Hylckama Vlieg J, Bermudez-Humaran LG, Smokvina T, Langella P. Bifidobacterium animalis ssp. lactis CNCM-I2494 Restores Gut Barrier Permeability in Chronically Low-Grade Inflamed Mice. Front Microbiol. 2016 May 6;7:608. doi: 10.3389/fmicb.2016.00608. eCollection 2016.

    PubMed 27199937

  • Hughes KR, Harnisch LC, Alcon-Giner C, Mitra S, Wright CJ, Ketskemety J, van Sinderen D, Watson AJ, Hall LJ. Bifidobacterium breve reduces apoptotic epithelial cell shedding in an exopolysaccharide and MyD88-dependent manner. Open Biol. 2017 Jan;7(1):160155. doi: 10.1098/rsob.160155.

    PubMed 28123052

  • Fornai M, Pellegrini C, Benvenuti L, Tirotta E, Gentile D, Natale G, Ryskalin L, Colucci R, Piccoli E, Ghelardi E, Blandizzi C, Antonioli L. Protective effects of the combination Bifidobacterium longum plus lactoferrin against NSAID-induced enteropathy. Nutrition. 2020 Feb;70:110583. doi: 10.1016/j.nut.2019.110583. Epub 2019 Sep 12.

    PubMed 31739175

Questions about this trial

What is this clinical trial studying?

An observational study of Neurodevelopmental Disorders, run by Instituto de Genética Médica y Molecular at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbiota (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200935, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.

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